← Product Code [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD) · K253166 # F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (K253166) _BMC Medical Co., Ltd. · BZD · Apr 29, 2026 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K253166 ## Device Facts - **Applicant:** BMC Medical Co., Ltd. - **Product Code:** [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD.md) - **Decision Date:** Apr 29, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5905 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic, Pediatric ## Indications for Use The Nasal Pillows Interface (P6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Nasal Pillows Interface (P6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. The Full Face Mask (F6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Full Face Mask (F6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. ## Device Story F6S Full Face Mask and P6S Nasal Pillows Interface are patient interfaces for CPAP/bi-level therapy. Devices channel airflow non-invasively from a positive airway pressure device to the patient via a tube connection above the head. F6S seals around nose/mouth; P6S seals at nares. Components include cushion assembly, tube, elbow assembly, and headgear. Used in home environment by patients > 66 lbs. Airflow is vented through holes in cushion and elbow. Healthcare providers prescribe therapy; patients operate device at home. Output is delivered air pressure; device facilitates therapy compliance and respiratory support. ## Clinical Evidence Bench testing only. Performance testing included deadspace, exhaust flow, pressure drop, CO2 rebreathing, cleaning validation, aging, transportation, and sound levels. Biocompatibility testing performed per ISO 10993 and ISO 18562 series. All tests met acceptance criteria per ISO 17510:2015, ISO 5356-1:2015, and ASTM D4169-22. ## Technological Characteristics Non-invasive patient interface; silicone cushion assembly; tubular conduit; 22mm swivel connector (ISO 5356-1). Energy source: external PAP device. Materials biocompatible per ISO 10993/18562. Cleaning: liquid dish detergent. No software/electronics. ## Regulatory Identification A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing. ## Predicate Devices - DreamWear Silicone Pillows Mask ([K210844](/device/K210844.md)) - AirFit F30i NM Mask System ([K234134](/device/K234134.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 29, 2026 BMC Medical Co., Ltd. Nicole Niu Regulatory Affairs Manager Rm. 10, 17f, Bldg. 4, Huiya Plz., # 16 Lize Rd. Fengtai District Beijing, 100073 China Re: K253166 Trade/Device Name: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 26, 2026 Received: March 26, 2026 Dear Nicole Niu: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} K253166 - Nicole Niu Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K253166 - Nicole Niu assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Binoy J. Mathews -S For Rachana Visaria Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K253166 | | | Device Name F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | | | Indications for Use (Describe) | | | The Nasal Pillows Interface (P6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Nasal Pillows Interface (P6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. | | | The Full Face Mask (F6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Full Face Mask (F6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} BMC Medical Co. Ltd. 510(k) Summary Page 1 of 11 Date Prepared: 23-March-2026 Sponsor: BMC Medical Co., Ltd Room 10, 17F, Building 4, Huiya Plaza, No. 16 Lize Road, Fengtai District, Beijing, China Submission Correspondent: Nicole Niu Regulatory Affairs Manager E-mail: niuxiaowei@bmc-medical.com Tel: +86-10-5166 3880 Prepared and submitted by: Amy Wang Regulatory Affairs Specialist E-mail: wangliping@bmc-medical.com Tel: +86-10-5166 3880 Proprietary or Trade Name: Full Face Mask (F6S) and Nasal Pillow Interface (P6S) Common/Usual Name: CPAP Mask Classification Name: Ventilator, Non-Continuous (Respirator) Product Code: BZD Predicate Device: DreamWear Silicone Pillows Mask - K210844 Common/Usual Name: CPAP Mask Classification Name: Ventilator, Non-Continuous (Respirator) Product Code: BZD Predicate Device: AirFit F30i NM Mask System - K234134 Common/Usual Name: CPAP Mask Classification Name: Ventilator, Non-Continuous (Respirator) Product Code: BZD Device Description: The Full Face Mask (F6S) and the Nasal Pillows Interface (P6S) are both intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. Both devices are used by patients (> 66 lbs./30 kg) for whom positive airway pressure therapy has been prescribed; and intended for single-patient re-use in the home environment. As the device names indicate, the Full Face Mask provides a seal around the patient’s nose and mouth, whereas the nasal pillows interface provides a seal at the entrance to the nares. Both devices {5} BMC Medical Co. Ltd. 510(k) Summary Page 2 of 11 use a cushion assembly and a tube connection above the head. To breathe fresh air, the mask features vent holes in the cushion and elbow. The mask is comprised of: 1. Cushion assembly 2. Tube 3. Elbow assembly 4. Headgear and Soft sleeves (optional accessory) ## Principle of Operation: Both the F6S Full Face Mask and P6S Nasal Pillows Interface are connected to a positive airway pressure device through breathing tube where the device channels airflow non-invasively to the patient. ## Indications for Use: The Nasal Pillows Interface (P6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Nasal Pillows Interface (P6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. The Full Face Mask (F6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Full Face Mask (F6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. ## Patient Population: Patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. ## Environments of use: Home environment ## Biocompatibility Biocompatibility testing was performed in accordance with the following standards: - ISO 10993-5 – Cytotoxicity - ISO 10993-10 – Sensitization - ISO 10993-23 – Intracutaneous Reactivity - ISO 10993-11 – Material Mediated Pyrogenicity - ISO 18562-1 – Breathing Gas Pathway Devices Biocompatibility - ISO 18562-2 – Particulate Matter Release - ISO 18562-3 – VOCs Emissions with ISO 18562-1 for TRA - ISO 18562-4 – Leachates in Condensates/ISO 10993-18 – Chemical characterization with ISO 18562-1/ISO 10993-17 for TRA ## Non-clinical Testing Performance testing demonstrated that the subject device met its acceptance criteria. Testing included, evaluation of deadspace, exhaust flow, pressure drop, CO₂ rebreathing, cleaning validation, aging, transportation, and sound power and pressure levels. All applicable tests were conducted in accordance with ISO 17510:2015 (Medical Devices for Sleep Apnea Breathing Therapy) and ISO 5356-1:2015, and ASTM D4169-22, confirming that both the F6S and P6S meet the applicable performance and safety requirements for their intended use. {6} BMC Medical Co. Ltd. 510(k) Summary Page 3 of 11 ## Substantial Equivalence Discussion ### Indications for Use – The indications for use for the subject device Nasal Pillows Interface (P6S) is identical to the predicate. The indications for use for the subject device Full Face Mask (F6S) has been slightly modified, but the change does not impact substantial equivalence predicate. ### Discussion – There is no meaningful difference in the indications for use between the subject and predicate device – DreamWear Silicone Pillows Mask – K210844 and AirFit F30i NM Mask System – K234134. Note: predicate AirFit F30i NM Mask System – K234134 had four models cleared in the original submission. We have removed references to the other device in that submission and claim substantial equivalence only to the AirFit F30i NM Mask System. ### Technology and construction – The technology and construction for both the subject device Nasal Pillows Interface (P6S) and Full Face Mask (F6S) are similar to the identified predicate devices. The Full Face Mask (F6S) offers different size masks, but performance testing shows similar device performance when compared to the predicate. The predicate refers to a frame, which is similar to the subject device construction that is referred to as “tube”. The mask uses a cushion assembly that seals under the nose (and around the mouth for the full-face mask) while the adjustable straps of the headgear hold the mask in place. ### Discussion – The differences between the subject and predicate device DreamWear Silicone Pillows Mask – K210844 and AirFit F30i NM Mask System – K234134 – do not raise any new concerns of safety as the functional technology is similar. Note: predicate AirFit F30i NM Mask System – K234134 had four models cleared in the original submission. We have removed reference to the other device in that submission and claim substantial equivalence only to the AirFit F30i NM Mask System. ### Environment of Use – The environment of use is identical. ### Discussion – The environments of use are identical to the predicate – DreamWear Silicone Pillows Mask – K210844 and AirFit F30i NM Mask System – K234134. Note: predicate AirFit F30i NM Mask System – K234134 had four models cleared in the original submission. We have removed references to the other device in that submission and claim substantial equivalence only to the AirFit F30i NM Mask System. ### Patient Population – The patient population of the subject device and predicate is identical. ### Discussion – The patient population is equivalent to the predicate device – DreamWear Silicone Pillows Mask – K210844 and AirFit F30i NM Mask System – K234134. ## Substantial Equivalence Conclusion The performance and technological characteristics of the subject devices have demonstrated that they are substantially equivalent to the predicate devices – DreamWear Silicone Pillows Mask – K210844 and AirFit F30i NM Mask System – K234134. The differences do not raise new questions of safety and effectiveness. {7} BMC Medical Co. Ltd. 510(k) Summary Page 4 of 11 | | Subject Device P6S Nasal Pillows Interface | Predicate Device DreamWear Silicone Pillows Mask | Comparison | | --- | --- | --- | --- | | Applicant | BMC Medical Co., Ltd. | Respironics, Inc. | / | | K# | K253166 | K210844 | / | | Product Code | BZD | BZD | Identical | | CFR | 21 CFR 868.5905 | 21 CFR 868.5905 | Identical | | Classification | II | II | Identical | | Indications for Use | The Nasal Pillows Interface (P6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Nasal Pillows Interface (P6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. | The DreamWear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed. | Similar We have slightly modified the indications language, but the change does not impact substantial equivalence | | Patient Population | Patients (>66 lbs./30kg) | Patients (>66 lbs./30kg) | Identical | | Environment of Use | Home | Home or hospital/institutional environment | The subject device is not intended for use in the hospital/institutional environment | | Patient Usage Type | Single patient re-use | Single patient use or multi patient use | The subject device is not intended for multi patient use | | Anatomical Sites | Nose | Nose | Identical | | Provided Sterile or Non-Sterile | Non-sterile | Non-sterile | Identical | | Pressure Range Specification | 4 to 25 cmH_{2}O | 4 to 30 cm H_{2}O | Similar | | Deadspace Volume | S Tube S Cushion – 98 ml M Cushion – 99 ml L Cushion – 101 ml | S Frame S Cushion – 73 ml M Cushion – 74 ml MW Cushion – 75 ml L Cushion – 78 ml | Similar. Meet the requirements of ISO17510:2015. | {8} BMC Medical Co. Ltd. 510(k) Summary Page 5 of 11 | | Subject Device P6S Nasal Pillows Interface | | | | | | Predicate Device DreamWear Silicone Pillows Mask | | | Comparison | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | M Tube S Cushion – 101 ml M Cushion – 102 ml L Cushion – 104 ml | | | | | | Medium Frame S Cushion – 76 ml M Cushion – 77 ml MW Cushion – 78 ml L Cushion – 81 ml | | | | | | | L Tube S Cushion – 107 ml M Cushion – 108 ml L Cushion – 110 ml | | | | | | Large Frame S Cushion – 78 ml M Cushion – 80 ml MW Cushion – 81 ml L Cushion – 84 ml | | | | | | Pressure Drop | Drop in Pressure (for three size cushions): at 50 L/min: 0.5 cmH₂O at 100 L/min: 1.5 cmH₂O | Drop in Pressure (cm H₂O) | | at 50 SLPM | at 100 SLPM | Similar. Meet the requirements of ISO17510:2015. | | | | | | | | | | | | | | Cushion Size | S | 1.3 | 4.8 | | | | | | | | | | | M | 1.2 | 4.3 | | | | | | | | | | | L | 1.1 | 3.8 | | | Sound Power and Pressure Level | Measured Sound Pressure Level: 28dBA Measured Sound Power Level: 20dBA | | | | | | Measured Sound Pressure Level: 27dBA Measured Sound Power Level: 19dBA | | | Similar | | | Total Mask Leak | For three size cushions: | | | | | | 4 cm H₂O S Cushion – 18.4 SPLM M Cushion – 18.9 SPLM MW Cushion – 19.3 SPLM L Cushion – 19.6 SPLM 5 cm H₂O S Cushion – 21 SPLM M Cushion – 21.4 SPLM MW Cushion – 21.9 SPLM L Cushion – 22.3 SPLM 10 cm H₂O S Cushion – 31.7 SPLM M Cushion – 32.3 SPLM MW Cushion – 33.2 SPLM | Similar | | | | | | Pressure (cmH₂O) | 4 | 9 | 12 | 15 | 20 | | | | 25 | | | | Flow rate (L/min) | 17 | 26 | 31 | 36 | 43 | | | | 50 | | | | | | | | | | | | | | | {9} BMC Medical Co. Ltd. 510(k) Summary Page 6 of 11 | | Subject Device P6S Nasal Pillows Interface | Predicate Device DreamWear Silicone Pillows Mask | Comparison | | --- | --- | --- | --- | | | | L Cushion – 32.9 SPLM 20 cm H_{2}O S Cushion – 48.9 SPLM M Cushion – 50.1 SPLM MW Cushion – 51.2 SPLM L Cushion – 49.5 SPLM 30 cm H_{2}O S Cushion – 64.8 SPLM M Cushion – 66.5 SPLM MW Cushion – 67.6 SPLM L Cushion – 64.4 SPLM | | | CO2 Rebreathing (ETCO2%) | Results: Small Cushion with Large Tube 4 cm H_{2}O – 2.8% 5 cm H_{2}O – 2.2% 10 cm H_{2}O – -2.6% Results: Medium Cushion with Large Tube 4 cm H_{2}O – 3.0% 5 cm H_{2}O – 1.8% 10 cm H_{2}O – -2.4% Results: Large Cushion with Large Tube 4 cm H_{2}O – 4.2% 5 cm H_{2}O – 2.2% 10 cm H_{2}O – -2.4% | Results: MW Cushion with Large Frame 4 cm H_{2}O – 5.0% 5 cm H_{2}O – 5.0% 10 cm H_{2}O – 5.0% | Similar. Meet the requirements of ISO17510:2015. | | Reprocessing Methods | Air path and non-air path components – Cleaning with liquid dish detergent | Air path and non-air path components – Cleaning with liquid dish detergent Air path components – High level chemical and thermal disinfection Non-air path components thermal disinfection | Similar. The cleaning method has been validated. | {10} BMC Medical Co. Ltd. 510(k) Summary Page 7 of 11 | | Subject Device P6S Nasal Pillows Interface | Predicate Device DreamWear Silicone Pillows Mask | Comparison | | --- | --- | --- | --- | | **Cushion Design** | A silicone nasal pillows cushion with tips that seal at the entrance to the nares. The cushion contains exhalation ports | A silicone nasal pillows cushion with tips that seal at the entrance to the nares. The cushion contains exhalation ports | Similar | | **Frame Design** | The tube connects to nasal cushion; Two slots exist for insertion of headgear straps | The tubing frame connects to nasal cushion; Two slots exist for insertion of headgear straps, or headgear stabilizer arms | Similar | | **Exhalation/Exhaust** | No separate exhalation device is required. Exhalation is built into the elbow and nasal cushions | No separate exhalation device is required. Exhalation is built into the elbow and nasal cushions | Similar | | **Headgear Design** | Headgear’s two straps connect to the Tube. | Headgear includes stabilizer arms that connect to the headgear strap and the slots on the mask frame. | Similar | | **Patient Circuit Connection** | 22 mm swivel connector | 22 mm swivel connector | Identical | | **Sizes** | One size headgear 3 nasal pillow cushion sizes: Small, Medium, Large The tube is available in three size: small, medium and large | One size headgear 4 nasal pillows cushion sizes: Small, Medium, Medium Wide, Large Three frame sizes: Small, Medium, Large | Similar | {11} BMC Medical Co. Ltd. 510(k) Summary Page 8 of 11 | | Subject Device Full Face Mask (F6S) | Predicate Device AirFit F30i Non Magnetic | Comparison | | --- | --- | --- | --- | | Applicant | BMC Medical Co., Ltd. | ResMed Corp. | / | | K# | K253166 | K234134 | / | | Product Code | BZD | BZD | Identical | | CFR | 21 CFR 868.5905 | 21 CFR 868.5905 | Identical | | Classification | II | II | Identical | | Indications for Use | The Full Face Mask (F6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Full Face Mask (F6S) is: • to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. • intended for single-patient re-use in the home environment. | The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment. This mask is for patients weighing more than 66 lbs. (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. | Substantially Equivalent Note: We have removed the following models (AirFit F30i, AirFit F30i SLM, AirFit F30i Non Magnetic SLM, from the predicate device indications for use as we do not intend to claim to substantial equivalence to all models included in K234134. | | Patient Population | Patients weighing more than 66 lbs. (30 kg) | Patients weighing more than 66 lbs. (30 kg) | Identical | | Environment of Use | Home | Home | Identical | | Patient Usage Type | Single patient re-use | Single patient re-use | Identical | | Anatomical Sites | Face | Face | Identical | {12} BMC Medical Co. Ltd. 510(k) Summary Page 9 of 11 | Provided Sterile or Non-Sterile | Non-sterile | | Non-sterile | | Identical | | --- | --- | --- | --- | --- | --- | | Pressure Range Specification | 4 to 30 cmH2O | | 4 to 30 cmH2O | | Identical | | Deadspace Volume | Small Tube S Cushion – 234 ml M Cushion – 240 ml L Cushion – 242 ml MW Cushion – 243 ml | | Small Frame S Cushion – 230 ml M Cushion – 235 ml SW Cushion – 240 ml W Cushion – 255 ml | | Similar Meet the requirements of ISO17510:2015. | | | Medium Tube S Cushion – 237 ml M Cushion – 243 ml L Cushion – 245 ml MW Cushion – 246 ml | | Medium Frame S Cushion – 235 ml M Cushion – 240 ml SW Cushion – 245 ml W Cushion – 260 ml | | Similar Meet the requirements of ISO17510:2015. | | | Large Tube S Cushion – 243 ml M Cushion – 248 ml L Cushion – 251 ml MW Cushion – 252 ml | | Large Frame S Cushion – 240 ml M Cushion – 245 ml SW Cushion – 250 ml W Cushion – 265 ml | | Similar Meet the requirements of ISO17510:2015. | | Pressure Drop (cm H2O) | Flow (L/min) | Pressure (cm H2O) | Flow (L/min) | Pressure (cm H2O) | Similar Meet the requirements of ISO17510:2015. | | | 50 | 0.5 | 50 | 0.2 | | | | 100 | 1.5 | 100 | 1.0 | | | Mask exhaust flow | Pressure (cm H2O) | Flow (L/min) | Pressure (cm H2O) | Flow (L/min) | Similar Meet the requirements of ISO17510:2015. | | | 4 | 22 | 4 | 22 | | | | 11 | 39 | 11 | 38 | | | | 12 | 41 | 17 | 48 | | | | 17 | 49 | 24 | 59 | | | | 24 | 59 | 30 | 67 | | | | 30 | 67 | | | | | CO2 Rebreathing (ETCO2%) Normal | F6S Small | | Pressure (cm H2O) | Relative CO2 increase | Similar Meet the requirements of ISO17510:2015. | | | Pressure (cm H2O) | CO2 increase | 4 | 7.7% | | | | 4hPa | 0.0% | 5 | 5.2% | | | | 5hPa | -3.00% | | | | {13} BMC Medical Co. Ltd. 510(k) Summary Page 10 of 11 | | 10hPa | -5.40% | 10 | 1.5% | | | --- | --- | --- | --- | --- | --- | | | F6S Medium | | | | | | | Pressure (cm H₂O) | Relative CO₂ increase | | | | | | 4hPa | 0.0% | | | | | | 5hPa | -1.80% | | | | | | 10hPa | -3.20% | | | | | | F6S Large | | | | | | | Pressure (cm H₂O) | Relative CO₂ increase | | | | | | 4hPa | -1.00% | | | | | | 5hPa | -3.00% | | | | | CO₂ Rebreathing (ETCO₂%) Single Fault Condition | F6S Mw | | | | | | | Pressure (cm H₂O) | Relative CO₂ increase | | | | | | 4 | -1.00% | | | | | | 5 | -5.00% | | | | | | 10 | -5.80% | | | | | | F6S Medium | | | | | | | Condition | Relative CO₂ increase | | | | | | Blockage of tube failure generate flow | 40.80% 50.40% | | | | | F6S Large Condition | F6S Medium | | | | | | | Condition | Relative CO₂ increase | | | | | | Blockage of tube failure generate flow | 40.60% 48.60% | | | | | | F6S Mw | | | | | | | Condition | Relative CO₂ increase | | | | | | Blockage of tube | 40.80% | | | | | | failure generate flow | 51.00% | | | | | | F6S Mw | | | | | {14} BMC Medical Co. Ltd. 510(k) Summary Page 11 of 11 | | Blockage of tube 40.20% failure generate flow 49.60% | | | | | --- | --- | --- | --- | --- | | **Anti-Asphyxia Valve Pressure (cmH_{2}O)** | Open < 4 cm H_{2}O Closed < 4 cm H_{2}O | Open < 4 cm H_{2}O Closed < 4 cm H_{2}O | | Similar Meet the requirements of ISO17510:2015. | | **Inspiratory and expiratory resistance under single fault condition (cmH_{2}O)** | Inspiratory 0.4 Expiratory 0.2 | Inspiratory 0.2 Expiratory 0.4 | | Similar Meet the requirements of ISO17510:2015. | | **Sound** | Sound power level: 26 dBA Sound pressure level: 18 dBA | Sound power level: 25 dBA Sound pressure level: 18 dBA | | Similar Meet the requirements of ISO17510:2015. | | **Cushion Design** | The mask uses a cushion assembly that seals under the nose (and around the mouth for the full-face mask offering) while the adjustable straps of the headgear hold the mask in place. | Oral nasal cradle cushion that seals under the nose and around the mouth | | Similar | | **Reprocessing** | Single patient re-use | Single patient re-use | | Identical | | **Frame Design** | Tubular conduit | Tubular conduit | | Similar | | **Headgear Design** | Available in one size Soft sleeves are optional | Available in one size | | Similar | | **Exhaust Port Location** | Elbow and cup | Elbow and cushion | | Similar | | **Sizes** | Small Medium Medium Wide Large | Small Cushion Medium Cushion Small Wide Cushion Wide Cushion | | Similar | | **PAP tubing connection point** | 22mm conical connector as per ISO 5356-1 over the head connection | 22mm conical connector as per ISO 5356-1 over the head connection | | Identical | --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K253166](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K253166) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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