Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

K251920 · Dcstar, Inc. · BZD · May 21, 2026 · Anesthesiology

Device Facts

• Record ID: K251920
• Device Name: Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
• Applicant: Dcstar, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: May 21, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. -The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment.

Device Story

Full face mask (JoyMask 20-B, 21-B) covers mouth and nose to deliver pressurized air from PAP device; comprises cushion, frame, elbow, and headgear. Cushion provides airtight seal; elbow acts as airflow conduit; includes exhalation port and anti-asphyxia valve (AAV) for CO2 flushing. Used in home environment by patients >30kg; prescription required. Clinician uses device to deliver prescribed therapy pressure; mask ensures effective airflow delivery to patient. Benefits include non-invasive airway support for sleep apnea management.

Clinical Evidence

No clinical data. Bench testing only, including dead space, exhaust flow, AAV pressure, resistance to flow, CO2 re-breathing, and sound levels per ISO 17510. Biocompatibility testing performed per ISO 10993 and ISO 18562 series.

Technological Characteristics

Full face mask with 22mm conical connector (ISO 5356-1). Pressure range 4-30 cmH2O. Non-sterile. Materials evaluated for biocompatibility per ISO 10993-5, -10, -23 and ISO 18562-2, -3, -4. Mechanical design includes AAV and exhalation port. No magnets.

Indications for Use

Indicated for adult patients (>30kg) requiring positive airway pressure therapy (CPAP or bi-level) for sleep apnea; intended for single-patient, multi-use in home environments.

Regulatory Classification

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

• Innova Full Face Vented Mask (K241830)

Reference Devices

• F&P Evora Full Face Mask (K212371)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 21, 2026

DCStar Inc.
Emma Chen
Regulatory Affairs Specialist
228 Park Ave S 30327
New York, New York 10003

Re: K251920
Trade/Device Name: Sleep Apnea Breathing Therapy Mask: JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
Regulation Number: 21 CFR 868.5905
Regulation Name: Noncontinuous Ventilator (IPPB)
Regulatory Class: Class II
Product Code: BZD
Dated: April 16, 2026
Received: April 16, 2026

Dear Emma Chen:

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.

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251920 - Emma Chen
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(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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K251920 - Emma Chen
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Sincerely,

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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
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) K251920 | |
| Device Name Sleep Apnea Breathing Therapy Mask:Joymask 20-B, Joymask 21-B | |
| Indications for Use (Describe) The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. -The mask is to be used by patients (weighing>30kg), intended for single patient reuse 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 [e-mail] | |
| "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." | |

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510(k) Summary

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

## Type of submission

Traditional

## Date prepared

5/21/2026

## Submitter's Information

Company: DCSTAR INC

Address: 228 PARK AVE S 30327, NEW YORK, NY, UNITED STATES, 10003

Submitter: Emma Chen

Telephone: [phone]

Email: [e-mail]

## Device Information

Device name: JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

Classification name: Non Continuous Ventilator (IPPB)

Production code: BZD

Regulation number: 21 CFR 868.5905

Classification: Class II

## Predicate Device Information

510(k) Number: K241830

Manufacturer: Sleepnet Corporation

Device Name: Innova Full Face Vented Mask

Device Class: Class II

Product Code: BZD

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510(k) Summary

# Reference Device Information

510(k) Number: K212371

Manufacturer: Fisher & Paykel Healthcare Ltd

Device Name: F&P Evora Full Face Mask

Device Class: Class II

Product Code: BZD

# Indications for use

The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system.

- The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment.

# Device Description

JoyMask 20-B and JoyMask 21-B are full face masks designed to cover the patient's entire mouth and nose, delivering therapeutic pressure through both airways. Each model comprises four main components: a cushion, frame, elbow, and headgear.

The headgear connects to the frame via a plastic clip, securing the cushion in place. The cushion ensures an airtight seal for effective airflow delivery, while the elbow serves as the conduit for the airflow itself.

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510(k) Summary

Substantial Equivalence Table

Table 1 Substantial Equivalence Comparison

| Item | Subject Device | Predicate Device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| Device | Sleep Apnea Breathing Therapy Mask - JoyMask 20-B and JoyMask 21-B | Innova Full Face Vented Mask | F&P Evora Full Face Mask | - |
| Product Code | BZD | BZD | BZD | Same |
| Regulation No. | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | Same |
| Indication for Use | The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system.-The mask is to be used by patients (weighing >30 kg), intended for single-patient reuse in the home environment. | Innova Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O.The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.Single patient, multi-use in the home or hospital/institutional environment. | The F&P Evora Full Face mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy.The F&P Evora Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses. | Equivalent to predicate device |
| Population | Used on adult patients (>30kg) requiring positive airway pressure therapy. | Used on adult patients (>30kg) requiring positive airway pressure therapy. | Used on adult patients (≥30kg) requiring positive airway pressure therapy. | Equivalent to predicate device |
| Duration and Environment of Use | Single-patient, multi-use in the home environment. | Single patient, multi-use in the home or hospital/institutional environment. | Single patient use in the homeMultiple patient use in the hospital or other clinical setting | Equivalent to predicate device |
| Prescription for Use | Yes | Yes | Yes | Same |
| Principle of Operation | Provides a seal over the face (nose and mouth) to allow for delivery of pressurized air from a positive pressure | Provides a seal over the face (nose and mouth) to allow for delivery of pressurized air from a positive | Provides a seal over the face (nose and mouth) to allow for delivery of pressurized air from a positive pressure | Same |

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510(k) Summary

| | device such as CPAP or bilevel device. Mask includes an exhalation port and AAV for flushing out exhaled CO2. | | | pressure device such as CPAP or bilevel device. Mask includes an exhalation port and AAV for flushing out exhaled CO2. | | | device such as CPAP or bilevel device. Mask includes an exhalation port and AAV for flushing out exhaled CO2. | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Non-sterile | Yes | | | Yes | | | Yes | | Same |
| Available Size | S, M, L | | | S, M, L | | | XS, S-M, L | | Equivalent to predicate device |
| Technical Specifications | | | | | | | | | |
| User Interface to administer therapy | 22mm conical connector (compliant with ISO 5356-1) | | | 22mm conical connector (compliant with ISO 5356-1) | | | 22mm conical connector (compliant with ISO 5356-1) | | Same |
| Dead Space | Size | Dead Space (ml) | | Size | Dead Space (ml) | | Size | Dead Space (ml) | Similar to predicate device The dead space are detailed in the IFU. |
| | Small | 175.6 | | Small | 155.3 | | Extra Small | 165.2 | |
| | Medium | 188.6 | | Medium | 181.7 | | Small-Medium | 162.6 | |
| | Large | 210.3 | | Large | 196.6 | | Large | 164.1 | |
| Pressure Range | 4 to 30 cmH2O | | | 3 to 20 cmH2O | | | 4 to 30 cmH2O | | Identical to reference device The pressure range, along with other technical specifications such as exhaust flow characteristics, is detailed in the IFU as a reference for clinicians. The difference from the predicate device do not introduce additional risks. |
| Therapy Pressure and its exhaust flow characteristics | Pressure (cmH2O) | | Flow (lpm) | Pressure (cmH2O) | Flow (lpm) | | Not Publicly Available | Similar to predicate device In accordance with ISO 17510, the therapy pressure and exhaust flow characteristics are detailed in | |
| | 4 | | 20.6 | 3 | 22.08 | | | | |
| | 11 | | 37.0 | 10 | 38.50 | | | | |
| | 17 | | 49.4 | 20 | 54.30 | | | | |
| | 24 | | 60.9 | | | | | | |

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510(k) Summary

| | 30 | 67.8 | | | the IFU as a reference for the clinicians. | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | | | |
| AAV Opening/Closing Pressure | Opening – 1.89 cmH2O Closing – 2.22 cmH2O | | Opening – 2.10 cmH2O Closing – 2.28 cmH2O | | Not Publicly Available | Similar to predicate device Meet the acceptance criteria as per ISO 17510 (<4 cmH2O). The AAV Opening/Closing Pressure are detailed in the IFU as a reference for the clinicians. |
| Resistance to Flow | 50 lpm – 0.48 cmH2O 100 lpm – 0.78 cmH2O | | 50 lpm – 0.07 cmH2O 100 lpm – 0.39 cmH2O | | 50 lpm – 0.9 ± 0.3 cm H2O 100 lpm – 2.2 ± 0.3cm H2O | Similar to predicate device In accordance with ISO 17510, the resistance values are detailed in the IFU as a reference for the clinicians. |
| Magnet | No Magnet | | No Magnet | | No Magnet | Same |
| CO2 re-breathing performance | Setting | Relative CO2 increase | Setting | Relative CO2 increase | Not Publicly Available | Similar to predicate device Meet the acceptance criteria as per ISO 17510 (<20% under normal condition and <60% under single fault condition). |
| | 4 cmH2O | 11.6% | 3 cmH2O | 16% | | |
| | 5 cmH2O | 9.4% | 5 cmH2O | 16% | | |
| | 10 cmH2O | 5.0% | 10 cmH2O | 12% | | |
| | Single Fault1 | 23.9% | Single Fault1 | 25% | | |
| | Single Fault2 | 30.7% | Single Fault2 | 45% | | |
| AAV Inspiratory/Expiratory Resistance in Single Fault Condition | Inspiratory – 0.89 cm H2O Expiratory – 0.63 cm H2O | | Inspiratory – 0.6 cm H2O Expiratory – 0.5 cm H2O | | Not Publicly Available | Similar to predicate device Meet the acceptance criteria as per ISO 17510 (<10 |

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510(k) Summary

| | | | | cmH2O). |
| --- | --- | --- | --- | --- |
| Sound Pressure and Sound Power Level | Sound Pressure – 27.0 dBA Sound Power – 34.1 dBA | Sound Pressure – 29.98 dBA Sound Power – 32.99 dBA | Sound Pressure: 20.2 dBA, with uncertainty 2.5 dBA Sound Power: 28.2 dBA, with uncertainty 2.5 dBA | Similar to predicate device In accordance with ISO 17510, the values are detailed in the IFU. |

## Substantial Equivalence Discussion

## Indications for Use

Both the subject devices and the predicate device are intended for use with Positive Airway Pressure (PAP) devices to provide airway pressure therapy for adult patients weighing over $30\mathrm{kg}$. Both devices are available by prescription only and are intended for single-patient, multi-use in the home environment. The minor differences between them are strictly limited to language expression.

Therefore, the indications for use of the subject devices (JoyMask 20-B and JoyMask 21-B) are considered identical to those of the predicate device (Innova Full Face Vented Mask). No new risks regarding the indications for use are introduced.

## Technical Characteristic and Performance

Both the subject devices and the predicate device are full-face masks designed to provide a seal over the user's face (covering both the nose and mouth) to deliver pressurized air from a positive airway pressure source.

In terms of technical characteristics, the subject devices are demonstrated to be similar to the predicate device and reference device. The minor technical differences have been fully evaluated in accordance with applicable standard and introduce no new risks. Therefore, the technical characteristics and performance of the subject devices (JoyMask 20-B and JoyMask 21-B) are substantially equivalent to those of the predicate device (Innova Full Face Vented Mask), raising no new questions of safety or effectiveness.

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510(k) Summary

## Performance Testing - Clinical
Not Applicable

## Performance Testing - Animal
Not Applicable

## Non-clinical testing
The following tests were conducted to verify the safety and effectiveness of subject devices.

## Performance Testing
The following technical characteristic have been verified:
Dead Space, Exhaust Flow Characteristics, AAV Pressure, Resistance to Flow, CO2 Re-breathing Performance, AAV Inspiratory/Expiratory Resistance, Sound Pressure and Sound Power Level

## Biocompatibility Testing
Biocompatibility testing was performed in accordance with the following standards:
- ISO 10993-5 – Cytotoxicity
- ISO 10993-10 – Sensitization
- ISO 10993-23 – Intracutaneous Reactivity
- ISO 18562-2 – Particulate Matter Release
- ISO 18562-3 – VOCs Emissions with Toxicological Risk Assessment
- ISO 18562-4 – Leachates in Condensates with Toxicological Risk Assessment

## Other Testing
- Transportation Testing
- Cleaning Validation
- Shelf Life and User Life Verification

## Recognized Standards/Guidance
The subject devices comply with the following standards/guidance
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff
- Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Guidance for Industry and Food and Drug Administration Staff

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ISO 17510:2015 - Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
ISO 5356: Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 17664: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-17:2023 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
ISO 10993-23:2021 - Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 18562-1:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
ISO 18562-2:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances
ISO 18562-4:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

## Conclusion

Based on the information above, the subject devices (JoyMask 20-B and JoyMask 21-B) and the predicate device (Innova Full Face Vented Mask) have the same indication for use and similar technical characteristic.

The SE discussion and relevant data have demonstrated that the subjects devices are substantially equivalent to the predicate device and the differences do not raise new questions of safety and effectiveness.