← Product Code [DQA](/productcode/DQA) · K253887 # Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) (K253887) _Philips Medizin Systeme · DQA · May 1, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253887 ## Device Facts - **Applicant:** Philips Medizin Systeme - **Product Code:** [DQA](/productcode/DQA.md) - **Decision Date:** May 1, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Pediatric ## Indications for Use The Nasal Alar SpO2 Sensor is intended for single patient use, for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing ≥15 kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments, where compatible pulse oximetry monitors are indicated for use, under professional supervision. ## Device Story Disposable, single-patient-use pulse oximetry sensor; attaches to nasal ala via soft silicone rubber cushions; integrates LEDs and photodiode. Connects to compatible Philips FAST SpO2 technology monitors via DB-9 cable. Operates via transmissive spectrophotometric measurement of functional arterial oxygen saturation. Used in various healthcare environments under professional supervision. Provides continuous SpO2 and pulse rate data to monitor; assists clinicians in assessing patient oxygenation status; benefits patients by providing reliable perfusion monitoring at nasal site, avoiding potential flow interruptions associated with distal sites like digits. ## Clinical Evidence Clinical SpO2 testing conducted per ISO 80601-2-61. Results confirmed an ARMS (Accuracy Root Mean Square) of ≤3% across the 70-100% range. Bench testing included biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and mechanical reliability. ## Technological Characteristics Materials: silicone rubber cushions, plastic body, new glue/coverlay formulations. Sensing: transmissive spectrophotometric pulse oximetry (LEDs/photodiode). Connectivity: wired DB-9 connector to compatible monitors. Ingress Protection: IP34. Standards: ISO 10993-1, ISO 80601-2-61, IEC 60601-1, IEC 60601-1-2. ## Regulatory Identification An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. ## Predicate Devices - Nasal Alar SpO₂ Sensor ([K171423](/device/K171423.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 May 1, 2026 Philips Medizin Systeme Jamie Palmer Principal, Regulatory Affairs Specialist Boblingen Gmbh Hewlett-Packard St. 2 Boblingen, 71034 Germany Re: K253887 Trade/Device Name: Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar SpO2 Sensor (989803205401) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 31, 2026 Received: April 1, 2026 Dear Jamie Palmer: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253887 - Jamie Palmer 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 {2} K253887 - Jamie Palmer Page 3 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Bradley Q. Quinn -S Bradley Quinn 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} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253887 | ? | | Please provide the device trade name(s). | | ? | | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar SpO2 Sensor (989803205401) | | | | Please provide your Indications for Use below. | | ? | | The Nasal Alar SpO2 Sensor is indicated for single patient use, for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing ≥15 kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments, where compatible pulse oximetry monitors are indicated for use, under professional supervision. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary # 510K SUMMARY | 1. Submitter | | | --- | --- | | Date Prepared: | 29 Apr 2026 | | Submitter/Owner: | Philips Medizin Systeme Böblingen, GmbH FDA Establishment Number: 9610816 Hewlett-Packard Str. 2 Böblingen, 71034 Germany Phone: +49 7031 4630 Fax: 07031-463 -2202 | | Key Contact: | Jamie L. Palmer Principal, Regulatory Affairs Specialist Jamie.Palmer@philips.com | | 510(k) Submission Type: | Traditional 510(k) | | 2. Device | | | --- | --- | | Trade Name(s): | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar SpO2 Sensor (989803205401) | | Common Name: | Oximeter | | Classification Name: | Device Class: II (Performance Standards) Product Code: DQA (Oximeter) Regulation Number: 21 CFR 870.2700 Review Panel: Cardiology | | 3. Predicate Device | | | | | --- | --- | --- | --- | | Predicate Device: | 510(k) No. | Company Name & Device Name | Product Code | | | K171423 | Company: Xhale Assurance, Inc. Device Name: Nasal Alar SpO₂ Sensor | DQA | PHILIPS Philips CAD (MCS/OBS) Page 1 of 10 {5} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary The Philips branded Nasal Alar SpO₂ Sensor is substantially equivalent to the legally marketed predicate, Xhale Assurance, Inc.'s, Nasal Alar SpO₂ Sensor cleared via K171423. ## 4. Device Description [21CFR 807.92 (a) (4)] The Nasal Alar SpO₂ Sensor is a disposable, single patient use pulse oximetry sensor. It has been designed to attach to the patient's nasal alar region (the fleshy region at the side of the nose) as the nasal ala provides a source of perfusion without the potential physiological interruption of sufficient blood flow that can occur when monitoring distal sites, such as the digits. The Nasal Alar SpO₂ Sensor attaches to the patient's ala via skin contacting, adhesive free, soft, silicone rubber cushions which encapsulate the optical components of the sensor. The Nasal Alar SpO₂ Sensor has been designed for connection to monitors that include or are compatible with Philips FAST SpO₂ technology, utilizing a DB-9 connector cable. The Nasal Alar SpO₂ Sensor is used as an accessory with the Oximeter (Monitors) as part of a System. The Philips Nasal Alar SpO₂ Sensor comprises three major components; a wire assembly attached to a flexible electrical circuit integrating the LEDs and photodiode; a molded plastic body; and molded silicone rubber cushions that consolidate the assembly and provide the point of skin contact to the patient. An applicator clip is provided with the sensor to allow for application of the sensor on the patient's nasal ala. ## 5. Intended Use as required per 21 CFR 807.92(a)(5) The Nasal Alar SpO₂ Sensor is intended for single patient use, for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing ≥15 kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments, where compatible pulse oximetry monitors are indicated for use, under professional supervision. PHILIPS Philips CAD (MCS/OBS) Page 2 of 10 {6} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary | 6. Comparison of Technological Characteristics with Predicate Device Acquired by Philips from Xhale Assurance, Inc. | | | --- | --- | | SIMILARITIES | | | Item of Comparison | Description/Rationale | | Oximeter (Monitor) Type | Those that include or are compatible with Philips FAST (Fourier Artifact Suppression Technology) SpO₂ technology. | | Measurement | - SpO₂ - Pulse Rate | | Measurement Method | Spectrophotometric measurement of functional arterial oxygen saturation by transmissive mode pulse oximetry. | PHILIPS Philips CAD (MCS/OBS) Page 3 of 10 {7} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary | Biocompatibility Assessment (ISO 10993-1) | Contact Classification Direct and indirect patient contact | | --- | --- | | Sensor Specifications | - Single-Patient Use - Worn up to 7 days each, 29 days total cumulative use - ARMS range of ≤3% across the range of 70-100% - 30-240 bpm ± 3 bpm | | Sensor Storage | -40° to 70°C (-40° to 158°F) | | Sensor Shelf-Life | Max 5 years Shelf Life | | DIFFERENCES | | | Item of Comparison | Description/Rationale | | Materials | The Nasal Alar SpO₂ Sensor utilizes a new glue formulation, updated colorants for the heat shrink tubing, and a new coverlay material that the Xhale Assurance, Inc, Nasal Alar SpO₂ Sensor predicate device did not. These materials also met the acceptance criteria of testing to ISO 10993-1 and are considered substantially equivalent. | | LEDS | A minor adjustment was made to the OPTO SMD Dual LED chip of the Nasal Alar SpO₂ Sensor. This change was designed to improve process yield at the component level, while maintaining the previously established specifications shared with the Xhale Assurance, Inc Nasal Alar SpO₂ Sensor predicate device. | | Labeling | Several labeling changes have been implemented. These labeling changes are all updates from the labeling of the Xhale Assurance, Inc. Nasal Alar SpO₂ Sensor predicate device. | PHILIPS Philips CAD (MCS/OBS) Page 4 of 10 {8} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary | Ingress Protection Rating | The Nasal Alar SpO₂ Sensor has an ingress protection rating of IP34 which is more stringent than the predicate, Xhale Assurance, Inc Nasal Alar SpO₂ Sensor’s rating of IPX1. | | --- | --- | | **SUBSTANTIAL EQUIVALENCE SUMMARY** | | | Operational and technological characteristics form the basis for the determination of substantial equivalence of the Nasal Alar SpO₂ Sensor with the legally marketed predicate device, the Xhale Assurance, Inc Nasal Alar SpO₂ Sensor (K171423). | | | • The differences do not raise new safety and effectiveness questions as compared to the legally marketed predicate device. • The minor differences in materials of the subject device do not raise different questions of safety and effectiveness. • Performance testing was conducted to support the subject device’s substantial equivalence to the predicate device. | | | The Nasal Alar SpO₂ Sensor is a modification of the Xhale Assurance, Inc Nasal Alar SpO₂ Sensor (K171423) and therefore is substantially equivalent to the predicate device. | | ## 7. Performance Data ### Recognized Consensus Standards The Nasal Alar SpO₂ Sensor has passed all safety tests for demonstrated compliance with the consensus standards listed below: | Standard | FDA Recognition # | Title # | | --- | --- | --- | | ISO 10993-1 | 2-258 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | | ISO 10993-5 | 2-245 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | PHILIPS Philips CAD (MCS/OBS) Page 5 of 10 {9} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary | ISO 10993-6 | 2-247 | Biological evaluation of medical devices- Part 6: Tests for local effects after implantation | | --- | --- | --- | | ISO 10993-10 | 2-296 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | | ISO 10993-11 | 2-255 | Biological evaluation of medical devices-Part 11: Tests for systemic toxicity | | ISO 10993-23 | 2-291 | Biological evaluation of medical devices- Part 23: Tests for irritation | | ISO 14971 | 5-125 | Medical Devices – Application of risk management to medical devices | | IEC 60601-1 | 19-49 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | | IEC 60601-1-2 | 19-36 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | IEC 60601-1-6 | 5-132 | Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance. Collateral standard: Usability | | ISO 14155 2^{nd} Ed | 2-282 | Clinical investigation of medical devices for human subjects — Good clinical practice | | ISO 80601-2-61 | 1-139 | Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | PHILIPS Philips CAD (MCS/OBS) Page 6 of 10 {10} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary # Non-Clinical Tests 1. Sterilization and Shelf Life Sterilization is not applicable to the Nasal Alar SpO₂ Sensor. The subject device is not designed to be sterilized. The Nasal Alar SpO₂ Sensor is a single-use, single-patient device and is disposed of upon use life or completion of treatment. The Nasal Alar SpO₂ Sensor has a defined maximum shelf-life of 5 years. This is supported by V&V testing to ensure product integrity, safety, and device performance over the defined shelf-life period has not been compromised or affected. 2. Biocompatibility The subject device met the acceptance criteria as defined in the test requirements. Results were deemed as 'PASS'. There were no unexpected results or significant deviations that would have affected the tests. Tests selected were based on contact and duration, as outlined in ISO 10993-1. - Cytotoxicity - Sensitization - Irritation - Implantation - Acute Systemic Toxicity - Subacute/Subchronic Toxicity 'Irritation' testing was conducted following ISO 10993-10. Based on testing, it was deemed that there was enough data to support the safety of the device without performing additional animal testing as per ISO 10993-2. 3. EMC, Wireless, Electrical, Mechanical, Thermal Safety and Ingress Protection Prior Electrical Safety and EMC testing of the predicate device, Xhale Assurance, Inc Nasal Alar SpO2 Sensor (K171423) was determined to be representative of the subject device, Nasal Alar SpO2 Sensor after assessment of the modifications. The Nasal Alar SpO2 Sensor is connected to the applicable patient monitor via cable and is not capable of wireless communication. PHILIPS Philips CAD (MCS/OBS) Page 7 of 10 {11} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary The Nasal Alar SpO2 Sensor was subjected to mechanical and thermal safety testing and was found to perform substantially equivalent to the predicate sensor. The Nasal Alar SpO2 Sensor and extender cable were evaluated for solid and liquid ingress protection. It was determined that the sensor, when mated with the corresponding SpO2 cable, met the requirements for an ingress protection rating of IP34. ## 4. Performance - Bench The following Performance Bench Tests were performed: | Test | Test Method | Acceptance Criteria | Result | | --- | --- | --- | --- | | Pull Test | Comparison of electrical continuity before pulling versus after pulling | 0.5V to 0.8V, verified by measuring the forward voltage drop of the diode in the connected probe. 1.5V to 1.8V verified by measuring the forward voltage drop of the LED in the connected probe. | Pass | | Shelf-life | Accelerated and real time aging per ASTM F1980 | 5 years | Pass | | Environmental-Reliability | Comparison of force values measured before and after testing | Force Measurement: Force after cycling is equal to the Force before cycling +/- 10% | Pass | | DB-9 Mating Force | Analysis of insertion and withdrawal force | Not Applicable – this test was to gather average insertion and withdrawal force of the Alar Sensor DB-9 connector | Not Applicable – this test was to gather average insertion and withdrawal force of the Alar Sensor DB-9 connector | | LED Transmission | Measured | LED RED | Pass | PHILIPS Philips CAD (MCS/OBS) Page 8 of 10 {12} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary | | transmission/current of the LED with a 20mA square wave at 1.2kHz | Transmission: Tred < 300 nA/mA LED IR Transmission: TIR < 700 nA/mA | | | --- | --- | --- | --- | | Pulse Rate | Comparison of displayed readings from the connected monitor versus a simulated pulse rate. | 30-240 bpm ± 3bpm | Pass | PHILIPS Philips CAD (MCS/OBS) Page 9 of 10 {13} PHILIPS Nasal Alar SpO₂ Sensor Traditional 510(k) 510(k) Summary ## Clinical Tests: Clinical SpO₂ testing was conducted per ISO 80601-2-61 to verify the accuracy of the Nasal Alar SpO₂ Sensor. The testing confirmed and overall ARMS of ≤3%. The data from the non-clinical and clinical testing supports the substantial equivalence of the subject device. ## 8. CONCLUSIONS The Nasal Alar SpO₂ Sensor is substantially equivalent to the predicate device in terms of: - The Indications and Intended Use, - Operating Principles, - Conditions of Use, and - Technological Characteristics. Verification and Validation (V&V) test results support that the technological characteristics of the Nasal Alar SpO₂ Sensor are substantially equivalent to the predicate device, Xhale Assurance, Inc. Nasal Alar SpO₂ Sensor (K171423). Risk Management activities, V&V testing, and Performance testing were conducted to support the substantial equivalence of the subject device per FDA recognized consensus standards, recognized industry standards, and internal protocol/procedures. PHILIPS Philips CAD (MCS/OBS) Page 10 of 10 --- **Source:** [https://fda.innolitics.com/device/K253887](https://fda.innolitics.com/device/K253887) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com