Cleared Traditional

K243086 - Unimed Reusable Finger Clip SpO2 Sensor...

Also marketed or referenced as:
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)

K243086 is an FDA 510(k) clearance for Unimed Reusable Finger Clip SpO2 Sensor..., 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 143-day FDA review.

K243086 · Unimed Medical Supplies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
143d
Days
Class 2
Risk

K243086 is an FDA 510(k) clearance for the Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91). 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 February 20, 2025 after a review of 143 days - within the typical 510(k) review window.

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 - K243086

510(k) Number K243086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date February 20, 2025
Days to Decision 143 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
3d slower than avg
Panel avg: 140d · This submission: 143d
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 K243086.
Avidhrt Sense SpO2
K241086 · Avidhrt, Inc. · May 2025
Pulse Oximeter ( PO2, PO2A, PO2B)
K242876 · Shenzhen Viatom Technology Co., Ltd. · Feb 2025
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
K233963 · Taiwan Aulisa Medical Devices Technologies, Inc. · Feb 2025
AViTA Pulse Oximeter (SP62B)
K242455 · Avita Corporation · Feb 2025
Unimed Reusable Finger Clip SpO2 Sensors (U103-125)
K242580 · Unimed Medical Supplies, Inc. · Feb 2025
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
K233956 · Taiwan Aulisa Medical Devices Technologies, Inc. · Jan 2025