Cleared Traditional

Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)

K242580 · Unimed Medical Supplies, Inc. · Anesthesiology
Feb 2025
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K242580 is an FDA 510(k) clearance for the Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125), a Oximeter (Class II — Special Controls, product code DQA), submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 6, 2025, 160 days after receiving the submission on August 30, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K242580 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2024
Decision Date February 06, 2025
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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