Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

K252821 · Philips Medizin Systeme Böblingen GmbH · DQA · May 29, 2026 · Cardiovascular

Device Facts

• Record ID: K252821
• Device Name: Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
• Applicant: Philips Medizin Systeme Böblingen GmbH
• Product Code: DQA · Cardiovascular
• Decision Date: May 29, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

These sensors are intended to be used by clinicians that have been appropriately trained, such as nurses, physicians, and EMS personnel. These sensors provide continuous, non-invasive measurement of arterial oxygen saturation (pulse rate signal and plethysmograph wave) to any SpO2 device that has passed validation testing. Either sensor can be comfortably clipped onto the finger of patients weighing > 40kg (typically adult patients).

Device Story

Reusable clip-style SpO2 sensors (M1196A, M1196T) for use with compatible Philips monitor/defibrillator systems. Sensors contain red and infrared light sources and a photodiode; measure arterial oxygen saturation via transmissive spectrophotometry. Input: red/IR light absorption signals; Output: SpO2 and pulse rate data. Used in hospital environments and during patient transport by trained clinicians (nurses, physicians, EMS). Output displayed on host monitor to assist clinical decision-making regarding patient oxygenation status. Benefits include continuous, non-invasive monitoring of patient vital signs.

Clinical Evidence

Single-center, non-randomized, desaturation study in healthy adult volunteers. Validated SpO2 accuracy against SaO2 from arterial blood samples analyzed via CO-Oximetry. Results confirmed an overall ARMS of ≤3%.

Technological Characteristics

Clip-style sensor with hard shell and soft inner material. Transmissive pulse oximetry using red/IR LEDs and photodiode. Non-sterile, reusable. Complies with IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 60601-1-12, IEC 62366-1, and ISO 10993-1.

Indications for Use

Indicated for non-invasive measurement of oxygen saturation (SpO2) and pulse rate in patients > 40 kg (typically adult patients).

Regulatory Classification

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

• Philips SpO2 Reusable Sensor, Models M1196A and M1196T (K062605)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 29, 2026

Philips Medizin Systeme Böblingen GmbH
Nicole Söder
Regulatory Affairs Specialist
Hewlett-Packard-Strasse 2
Böblingen, BW 71034
Germany

Re: K252821
Trade/Device Name: Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: Class II
Product Code: DQA
Dated: April 30, 2026
Received: April 30, 2026

Dear Nicole Söder:

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

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K252821 - Nicole Söder
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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.

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K252821 - Nicole Söder
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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).

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

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| 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. | K252821 | ? |
| Please provide the device trade name(s). | | ? |
| Reusable Adult SpO2 Clip Sensor (3m) (M1196A) Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | | |
| Please provide your Indications for Use below. | | ? |
| The Philips Reusable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate. M1196A and M1196T are indicated for patients > 40 kg (typically adult patients). | | |
| 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) | ? |

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PHILIPS
Philips Reusable SpO2 Sensors M1196A/M1196T
Traditional 510(k) 510(k) Summary

| 510(k) Summary | | | | |
| --- | --- | --- | --- | --- |
| Submitter | | | | |
| **Date Prepared** | May 28, 2026 | | | |
| **Submitter/Owner** | Philips Medizin Systeme Böblingen GmbH FDA Establishment Number 9610816 Hewlett-Packard-Str. 2 71034 Böblingen Germany | | | |
| **Key Contact** | Nicole Söder Regulatory Affairs Specialist [e-mail] Phone: [phone] | | | |
| **510(k) Submission Type** | Traditional 510(k) | | | |
| Device | | | | |
| **Model Numbers (#)** | M1196A & M1196T | | | |
| **Trade Name** | Reusable Adult SpO2 Clip Sensor | | | |
| **Common Name** | SpO2 Pulse Oximeter Sensor | | | |
| **Classification Name** | Panel & Name: Cardiovascular Devices Subpart & Division: 21 CFR §870.2700 Oximeter Regulatory Class: II Product Code: DQA | | | |
| Predicate Device | | | | |
| | **510(k) No.** | **Company** | **Device Name** | **Product Code** |
| **Predicate Device** | K062605 | Philips Medical Systems 3000 Minuteman RD. Andover, MA 01810 | Philips SpO2 Reusable Sensor, Models M1196A and M1196T | DQA |
| The subject devices are substantially equivalent to the legally marketed predicate devices. | | | | |
| Device Description | | | | |

PHILIPS
Philips Hospital Patient Monitoring
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PHILIPS
Philips Reusable SpO2 Sensors M1196A/M1196T
Traditional 510(k) 510(k) Summary

| Philips Reusable SpO2 Sensors M1196A/M1196T – description of the device per 21 CFR 807.92(a) (4) |
| --- |
| The Philips Reusable SpO2 Sensors M1196A/M1196T are used as accessories with compatible Philips Monitor/Defibrillator product lines as part of a System. |
| These Sensors measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. The Sensors contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value. |
| The Philips Reusable SpO2 Sensors M1196A/M1196T fall into the clip style category. Clip style Sensors follow the traditional SpO2 sensor design of a hard shell, to house the optical components, with a soft, contoured inner material meant to distribute the clamping pressure of the shell. |
| **Intended Use and Indication for Use** |
| **Intended Use as required per 21 CFR 807.92(a)(5)** |
| **Intended Use** These sensors are intended to be used by clinicians that have been appropriately trained, such as nurses, physicians, and EMS personnel. These sensors provide continuous, non-invasive measurement of arterial oxygen saturation (pulse rate signal and plethysmograph wave) to any SpO2 device that has passed validation testing. Either sensor can be comfortably clipped onto the finger of patients weighing > 40kg (typically adult patients). |
| **Indications for Use:** The Philips Reusable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate. M1196A and M1196T are indicated for patients > 40 kg (typically adult patients). |

Philips Hospital Patient Monitoring
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PHILIPS
Philips Reusable SpO2 Sensors M1196A/M1196T
Traditional 510(k) 510(k) Summary

| Comparison of Technological Characteristics with Predicate Device | |
| --- | --- |
| Similarities | |
| Item of Comparison | Description/Rationale |
| Intended Use/Indications for Use/Patient Population | The subject and predicate device do have the same intended use and indications for use. Intended Use/Indications for Use: Subject and predicate device provide continuous, non-invasive measurement of arterial oxygen saturation (pulse rate signal and plethysmograph wave) to any SpO2 device that has passed validation testing. Either sensor can be comfortably clipped onto the finger of patients weighing > 40kg (typically adult patients). |
| Principle of Operation | The subject and predicate device do have the same Principle of Operation. Spectrophotometric measurement of functional arterial oxygen saturation by transmissive mode pulse oximetry. |
| Anatomical Sites | The subject and predicate device are applied to any finger except thumb. |
| Environment of Use | The subject and predicate device are intended for use in hospital environments and for transport to a professional healthcare facility or between professional healthcare facilities. |
| Sterility | The subject and predicate device are non-sterile |
| Reusability | The subject and predicate device are reusable devices |
| Prescription Use | The subject and predicate device are prescription use only devices |
| Differences | |
| Material and Color | The subject device is made out of a more matte and opaque material. SpO2 Sensor housing, connector and cable colors have been changed. |
| LED and Photodiode (PD) | The positioning of the LED and photodiode (PD) was slightly changed for the subject device to optimize the light path. |
| Calibration Curve | Compared to the predicate device, the subject device applies a different calibration curve. This calibration curve is an existing and known calibration curve, already used in other SpO2 Sensors. |
| Clinical Study | The 510(k) included clinical data from Philips initiated laboratory tests with the intent to demonstrate the accuracy performance of the subject device. The clinical investigation provides supporting evidence that the proposed design changes tested with the subject device meet the existing SpO2 accuracy (ARMS) claims when validated in a large and diverse patient population. |

PHILIPS
Philips Hospital Patient Monitoring
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PHILIPS
Philips Reusable SpO2 Sensors M1196A/M1196T
Traditional 510(k) 510(k) Summary

| **Substantial Equivalence Summary** | | |
| --- | --- | --- |
| In accordance with 21 CFR Part 807, the Philips Reusable SpO2 Sensors M1196A/M1196T are substantially equivalent to the predicate devices. The differences identified between the subject devices and predicate devices do not raise new questions of safety and effectiveness. Performance testing confirms that the Philips Reusable SpO2 Sensors M1196A/M1196T are substantially equivalent to the predicate devices for Philips Monitor/Defibrillator product lines. The Philips SpO2 Reusable Sensor Models M1196A and M1196T (K062605) serve as the predicate devices. | | |
| **Performance Data** | | |
| **Recognized Standards** | | |
| The subject devices have passed all safety tests for demonstrated compliance with the recognized standards below: | | |
| Standard | FDA Recognition # | Title # |
| IEC 60601-1:2005+A1:2012+A2:2020 | 19-49 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | 19-36 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) | 1-139 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION | 19-39 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| IEC 62366-1:2015+AMD1:2020: | 5-129 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO 10993-1 Fifth edition 2018- | 2-258 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| **Non-Clinical Bench Testing** | | |
| The following Bench tests were performed to demonstrate the correct performance of the Philips Reusable SpO2 Sensors M1196A/M1196T: | | |

PHILIPS
Philips Hospital Patient Monitoring
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PHILIPS
Philips Reusable SpO2 Sensors M1196A/M1196T
Traditional 510(k) 510(k) Summary

- Interoperability testing, covering the performance between the Philips Reusable SpO2 Sensors and the host monitor device
- Material compatibility testing, covering material resistance to intended use and cleaning and disinfection
- Electronic Hardware testing, covering verification activities related to the applicable calibration curve, testing of optical requirements and testing of ranges, limits and tolerances
- Mechanical testing covering insertion and removal force testing
- Reliability testing covering bending, pull force and stress cycles
- Environmental testing

All above listed testing have met the specified acceptance criteria.

The data from the non-clinical testing supports the substantial equivalence of the subject device.

## Clinical Testing

SpO2 accuracy has been demonstrated through a clinical study performed with the Philips FAST Pulse Oximetry technology and the Philips Reusable SpO2 Sensors.

The performed clinical study is a single-center, non-randomized, desaturation study in healthy adult volunteers. The purpose was to validate the SpO2 accuracy of the Philips FAST Pulse Oximetry System against SaO2 obtained from arterial blood samples and analyzed by CO-Oximetry with consideration to anticipated FDA Guidance for Pulse Oximeters and ISO 80601-2-61 updates.

The testing confirmed and overall ARMS of ≤3%.

The data from clinical testing supports the substantial equivalence of the subject device.

## Conclusion

Substantial equivalence assessment, based on performance testing and taken together with the clinical study demonstrate that the subject devices do not raise different questions of safety and effectiveness when compared to the predicate device. The Philips Reusable SpO2 Sensors M1196A/M1196T perform as intended and have performance characteristics that are substantially equivalent to the predicate device.

PHILIPS
Philips Hospital Patient Monitoring
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