Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)

K251695 · Unimed Medical Supplies, Inc. · DQA · Nov 18, 2025 · Cardiovascular

Device Facts

• Record ID: K251695
• Device Name: Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
• Applicant: Unimed Medical Supplies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 18, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.

Device Story

Reusable SpO2 sensor (U403S-06) for continuous, non-invasive monitoring of arterial hemoglobin oxygen saturation and pulse rate. Device comprises a BCI DB9 connector, cable, and soft-tip patient-contacting sensor containing LEDs (660 nm/905 nm) and a photodetector. Operates via two-wavelength relative optical absorption principle; powered by host monitor. Used in professional healthcare environments by clinicians to monitor adult patients (>30 kg) under no-motion conditions. Output displayed on compatible host monitor (e.g., BCI SPECTRO2 10) to assist clinical decision-making regarding patient oxygenation status. Benefits include real-time physiological monitoring to detect hypoxemia.

Clinical Evidence

Clinical hypoxia study conducted per ISO 80601-2-61 on 12 adult volunteers (Fitzpatrick types 2-6, including 3 dark-skinned subjects). Study collected >200 data points comparing device SpO2 readings against co-oximetry SaO2. Results support accuracy claims for the specified saturation range.

Technological Characteristics

Reusable soft-tip sensor; materials include silicone (patient-contacting), copper/TPU cable, and BCI DB9 connector. Sensing via two-wavelength (660 nm/905 nm) optical absorption. Powered by host monitor. Biocompatibility per ISO 10993-5, -10, -23. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; performance per ISO 80601-2-61.

Indications for Use

Indicated for continuous, non-invasive monitoring of SpO2 and pulse rate in adult patients >30 kg, including well or poorly perfused individuals, in professional healthcare settings under no-motion conditions.

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

• Unimed Disposable and Reusable SPO2 Sensors (K142832)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 18, 2025

Unimed Medical Supplies, Inc.
Huanyu Zeng
Regulatory Affairs Specialist
Bld#8, Nangang 3rd Industrial Park, Tangtou,
Shiyan, Baoan District
Shenzhen, 518108
China

Re: K251695
Trade/Device Name: Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06)
Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: Class II
Product Code: DQA
Dated: October 17, 2025
Received: October 17, 2025

Dear Huanyu Zeng:

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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K251695 - Huanyu Zeng
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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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K251695 - Huanyu Zeng
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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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Unimed Reusable SpO2 Sensors (-06 Series)
Page 9 of 56

| 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. | K251695 | ? |
| Please provide the device trade name(s). | | ? |
| Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06) | | |
| Please provide your Indications for Use below. | | ? |
| Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only. | | |
| 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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A brand of Xinwell
unimed medical supplies

# 510K Summary

## 1. Submitter

**Submission Date:** Jun. 2, 2025

**Submitter/Manufacturer:** Unimed Medical Supplies Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan District, Shenzhen, China 518108
FDA Establishment Number: 3007307487

**Contact:**
Zeng Huanyu
RA Specialist
Tel: [phone]
E-mail: [e-mail]

**510(k) Submission Type** This is a traditional 510(k).

## 2. Proposed Device

**Trade Name:** Unimed Reusable SpO₂ Sensors (-06 Series)

**Common Name:** Oximeter Sensor

**Model Numbers** U403S-06

**Classification:**
Medical Specialty: Cardiovascular
Regulation: 21 CFR 870.2700 – Oximeter
Product Code: DQA
Class: II

## 3. Predicate Device

| Predicate Device | |
| --- | --- |
| 510(K) No. | Trade Name |
| K142832 | Unimed Disposable and Reusable SPO2 Sensors |

## 4. Device description

The subject device (U403S-06) is Unimed Reusable SpO2 Sensor and are fully compatible for use with BCI SPECTRO2 10. The sensor is supplied non-sterile.

The subject sensor consists of a plug/connector (BCI DB9 sensor connector), a cable (1.1 m), and a patient-contacting sensor (soft tip: U403S-06) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensor shares the same principle of

Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China
http://www.unimed.cn E-mail: [e-mail]

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A brand of Xinwell
unimed medical supplies

operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensor has identical material composition and performance characteristics to the predicate device.

The purpose of the submission is to receive clearance to market U403S-06 under their own 510k.

# 5. Intended use/Indications for use

Unimed Reusable $\mathrm{SpO}_2$ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin ($\mathrm{SpO}_2$) and pulse rate (PR) in adult patients weighing greater than $30\,\mathrm{kg}$ who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.

Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China
http://www.unimed.cn E-mail: [e-mail]

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A brand of Xinwell

unimed

medical supplies

6. Comparison to predicate devices

| Feature | Subject Device
(Model: U403S-06) | Predicate Device
(Model: U403-06, K142832) | Comparison to Predicate Device |
| --- | --- | --- | --- |
| General Information | | | |
| Device name | Unimed Reusable SpO₂ Sensors (-06 Series) | Unimed Disposable and Reusable SPO2 Sensors | / |
| Classification Regulation/Product Code | 21 CFR 870.2700, Class II/DQA | 21 CFR 870.2700, Class II/DQA | Substantially equivalent |
| Intended use/Indications for use | Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only. | Unimed Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate(PR) for adult patients weighing greater than 40 kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg. | Substantially equivalent |
| Principle of operation | Two-wavelength relative optical absorption | Two-wavelength relative optical absorption | Identical |
| Key performance specifications/ characteristics | | | |
| Intended patient population | Adult | Adult/Pediatric/Infant/Neonate | Substantially equivalent |
| Intended application site | Finger | Finger or toe | Substantially equivalent |

Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China

http://www.unimed.cn E-mail: [e-mail]

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A brand of Xinwell

unimed

medical supplies

| Feature | Subject Device
(Model: U403S-06) | Predicate Device
(Model: U403-06, K142832) | Comparison to Predicate Device |
| --- | --- | --- | --- |
| Prescription or OTC | Rx Only | Rx Only | Identical |
| Use type | Reusable | Disposable/Reusable | Substantially equivalent |
| Sensor Structure Composition | Sensor connector, cable,
LED&PD, soft tip | Sensor connector, cable,
LED&PD, adhesive tape/finger
clip/soft tip | Substantially equivalent¹ |
| Raw material | Sensor connector: BCI DB9
connector.
Cable: Copper conductor in TPU
jacket.
LED wavelength: 660 nm/905 nm
Patient-contacting material: Silicone | Cable: Copper conductor in PVC
jacket
LED wavelength: 660nm/905nm
Patient-contacting material: ABS/Silicone | Substantially equivalent |
| Performance (Arms) | | | |
| Saturation Accuracy,
No Motion (70-100%) | ±3% (70-100%) | ±3% (70-100%) | Identical |
| Pulse Rate Accuracy,
No Motion | ±3 bpm (30-250 bpm) | ±3 bpm (30-250 bpm) | Identical |
| Low Perfusion Accuracy | SpO₂ ±3% (70-100%) | ±3% (70-100%) | Identical |
| | Pulse ±3 bpm (30-250 bpm) | Pulse ±3 bpm (30-250 bpm) | Identical |
| Environmental | | | |
| Operating/Storage Temperature | Operating temperature: 5 to 40 °C
Storage temperature: -25 to 55 °C | Operating temperature: 5 to 40 °C
Storage temperature: -25 to 55 °C | Identical |
| Operational/Storage Humidity | 10 to 85% | 10 to 85% | Identical |
| Biocompatibility | Pass ISO 10993 cytotoxicity, skin | Pass ISO 10993 cytotoxicity, skin | Identical |

Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China

http://www.unimed.cn E-mail: [e-mail]

{8}

A brand of xinwell
unimed
medical supplies
U

| Feature | Subject Device
(Model: U403S-06) | Predicate Device
(Model: U403-06, K142832) | Comparison to Predicate Device |
| --- | --- | --- | --- |
| | irritation and skin sensitivity tests | irritation and skin sensitivity tests | |
| Energy source | Monitor power supply | Monitor power supply | Identical |

1. The subject device has the same technological characteristics (i.e., principle of operation, energy source, etc.) as the predicate device identified above, except for the design. The subject device U403S-06 is soft tip sensor and the predicate device U403-06 is finger clip sensor. The difference is validated by bench performance and clinical testing.

Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China
http://www.unimed.cn E-mail: [e-mail]

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A brand of Xinwell
unimed medical supplies

# 7. Verification and validation testing

## Non-clinical test data

Non-clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The conducted non-clinical tests conformed to the following recognized standards:

- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020)
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014+AMD1:2020)
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, COR1: 2018)
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation

The subject sensor includes silicone housing as patient-contacting component. The type of contact is contact with intact skin and the contact duration is defined as prolonged exposure per ISO 10993-1:2018 (medical devices whose cumulative sum of single, multiple or repeated contact time is likely to exceed $24\mathrm{h}$ but not exceed $30\mathrm{d}$). Therefore, our biocompatibility testing has been specifically designed to meet the corresponding endpoint assessment requirements, including the following tests:

- Cytotoxicity
- Skin sensitization
- Skin irritation

The results of these tests demonstrate the biocompatibility of the subject devices.

## Clinical test data

A clinical study was conducted under an approved protocol with subject informed consent to determine the accuracy of proposed device. The clinical studies were conducted per following standards:

Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China
http://www.unimed.cn E-mail: [e-mail]

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A brand of Xinwell
unimed medical supplies

- ISO 80601-2-61 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff

Clinical hypoxia test results were obtained in human adult volunteers (the study population includes sufficient darkly pigmented subjects) to validate the accuracy of the subject devices versus arterial oxygen saturation (SaO₂) as determined by co-oximetry.

Twelve subjects (7 males and 5 females, Fitzpatrick Type 2-6) were enrolled for the clinical study. The Fitzpatrick Scale was used to determine their skin pigmentation scores. Three dark subjects (Fitzpatrick Type 5-6) in this study allow a proper evaluation of the sensor accuracy in dark population. The study contains more than the minimum 200 data points, and the clinical study results support device accuracy claims for the specified saturation range.

## 8. Substantial Equivalence Statement

Based on the comparison, analysis, and the submitted verification and validation data, Unimed believes that the Unimed Reusable SpO₂ Sensors are as safe and effective and are substantially equivalent to the predicate device.

Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China
http://www.unimed.cn E-mail: [e-mail]