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Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91, U410-91)

by Unimed Medical Supplies, Inc.

510(k) K243086

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK243086 Date20 Feb 2025ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
510(k) Number
FDA Product Code
DQA
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Unimed Reusable Finger Clip SpO2 Sensors are reusable finger clip sensors for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). They are compatible with Philips Intellivue MP30 monitors and work by inputting optical signals via a finger clip. The devices are for prescription use only and are intended for adult patients weighing greater than 30 kg.

The Unimed Reusable Finger Clip SpO2 Sensors are supplied in two models, U403-91 and U410-91, and are classified as oximeters with a product code of DQA. They have been found to be substantially equivalent and have an FDA 510K number of K243086. The devices are reusable and are used in the cardiovascular medical specialty.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What are the Unimed Reusable Finger Clip SpO2 Sensors used for?

    The Unimed Reusable Finger Clip SpO2 Sensors are used for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg.

  • Are the Unimed Reusable Finger Clip SpO2 Sensors single-use or reusable?

    The Unimed Reusable Finger Clip SpO2 Sensors are reusable, and come in two models, U403-91 and U410-91.

  • What monitors are the Unimed Reusable Finger Clip SpO2 Sensors compatible with?

    The Unimed Reusable Finger Clip SpO2 Sensors are compatible with Philips Intellivue MP30 monitors.