Cleared Traditional

K251691 - Unimed Reusable SpO2 Sensors (-08 Serie...

Also marketed or referenced as:
Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08) Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08) Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)

K251691 is an FDA 510(k) clearance for Unimed Reusable SpO2 Sensors (-08 Serie..., manufactured by Unimed Medical Supplies, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K251691 · Unimed Medical Supplies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Dec 2025
Decision
182d
Days
Class 2
Risk

K251691 is an FDA 510(k) clearance for the Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 1, 2025 after a review of 182 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Unimed Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K251691

510(k) Number K251691 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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 140d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K251691.
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47
K253109 · Shenzhen Best Electronics Co., Ltd. · Jan 2026
Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48)
K251696 · Unimed Medical Supplies, Inc. · Dec 2025
Unimed Reusable SpO2 Sensors (-75 Series) (U410-75)
K251693 · Unimed Medical Supplies, Inc. · Nov 2025
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06)
K251695 · Unimed Medical Supplies, Inc. · Nov 2025