Cleared Traditional

K082546 - REUSABLE OHMEDA (U410-02)

K082546 is an FDA 510(k) clearance for REUSABLE OHMEDA (U410-02), 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 90-day FDA review.

K082546 · Unimed Medical Supplies, Inc. · Anesthesiology device
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Dec 2008
Decision
90d
Days
Class 2
Risk

K082546 is an FDA 510(k) clearance for the REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSO.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Unimed Medical Supplies, Inc. (Mukwonago, US). The FDA issued a Cleared decision on December 2, 2008 after a review of 90 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 - K082546

510(k) Number K082546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2008
Decision Date December 02, 2008
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 454
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