Cleared Traditional

K251696 - Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) (FDA 510(k) Clearance)

Also includes:

Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)

K251696 · Unimed Medical Supplies, Inc. · Anesthesiology device

Dec 2025

Decision

182d

Days

Class 2

Risk

K251696 is an FDA 510(k) clearance for the Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 1, 2025, 182 days after receiving the submission on June 2, 2025.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K251696 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 02, 2025
Decision Date	December 01, 2025
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF