Cleared Traditional

K251695 - Unimed Reusable SpO2 Sensors (-06 Serie...

Also marketed or referenced as:
Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06) Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)

K251695 is an FDA 510(k) clearance for Unimed Reusable SpO2 Sensors (-06 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 169-day FDA review.

K251695 · Unimed Medical Supplies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
169d
Days
Class 2
Risk

K251695 is an FDA 510(k) clearance for the Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06). 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 November 18, 2025 after a review of 169 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 - K251695

510(k) Number K251695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2025
Decision Date November 18, 2025
Days to Decision 169 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
29d slower than avg
Panel avg: 140d · This submission: 169d
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 K251695.
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08)
K251691 · Unimed Medical Supplies, Inc. · 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
Pulse Oximeter
K250837 · Shanghai Berry Electronic Tech Co., Ltd. · Sep 2025
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117)
K250931 · Unimed Medical Supplies, Inc. · Aug 2025
Avidhrt Sense SpO2
K241086 · Avidhrt, Inc. · May 2025