Skip to content

SpO2 Sensor

by Shenzhen Upnmed Equipment Co., Ltd.

510(k) K183277

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183277↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK183277 Date15 May 2019ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SpO₂ Sensor is a pulse oximetry device designed to measure oxygen saturation in arterial blood non-invasively. It operates by emitting light through a patient’s fingertip, toe, or earlobe and detecting the absorption differences between oxygenated and deoxygenated hemoglobin to provide real-time SpO₂ readings.

This sensor is supplied as a single-use, disposable component intended for use with compatible pulse oximeters in clinical and home-care settings. It requires no sterilization and is regulated under FDA 510(k) clearance (K183277) and EU MDR compliance, with no MRI safety restrictions specified. Sizes and configurations are determined by the manufacturer’s design for compatibility with pulse oximeter probes.

Other devices from Shenzhen UpnMed Equipment co., ltd

  • UpnMed

    Class IIb

  • UpnMed

    Class I

  • UpnMed

    Class I

  • UpnMed

    Class IIb

  • UpnMed

    Class IIb

  • Upnmed

    Class IIb

See all devices from Shenzhen UpnMed Equipment co., ltd →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical settings is this SpO₂ sensor designed for, and how does it differ from reusable sensors?

    This SpO₂ sensor is designed for both clinical and home-care settings, where non-invasive oxygen saturation monitoring is required. Unlike reusable sensors, it is single-use and disposable, eliminating the need for sterilization or cleaning between patients. This reduces cross-contamination risks and simplifies workflow, making it ideal for environments where hygiene and convenience are critical, such as hospitals, outpatient clinics, or patient homes.

  • How does the sensor determine oxygen saturation levels, and what body parts can it measure on?

    The sensor works by emitting light through a patient’s fingertip, toe, or earlobe and analyzing the absorption differences between oxygenated and deoxygenated hemoglobin. This allows it to calculate SpO₂ (oxygen saturation) levels non-invasively in real-time. The flexibility in measurement sites ensures compatibility with patients who may have difficulty using a single body part, such as those with cold extremities or limited mobility.

  • Is this sensor compatible with all pulse oximeters, or does it require specific equipment?

    The sensor is intended for use with compatible pulse oximeters—its design and sizing are tailored to work specifically with those models. While it is not universally compatible with every pulse oximeter on the market, the manufacturer ensures its configurations align with the intended devices. Always verify compatibility with your existing equipment before use to ensure accurate readings.

  • How should the sensor be stored, and what precautions should be taken before use?

    Since it is a single-use, disposable sensor, storage should follow the manufacturer’s guidelines to maintain its integrity until use. Typically, this involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, ensure the sensor is not damaged or expired (check packaging for expiration dates) and handle it with clean hands or sterile gloves to avoid contamination before attachment to the patient.

  • What regulatory pathways does this sensor follow, and how does that affect its use in different regions?

    The sensor is cleared under FDA 510(k) (K183277) and complies with EU MDR, meaning it meets U.S. and European regulatory standards for safety and performance. This clearance ensures it can be legally marketed and used in those regions without additional restrictions. However, local healthcare providers should confirm compliance with regional guidelines, as some countries may have additional requirements for single-use medical devices.