Cleared Traditional

K081516 - MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081516 · Medsource International, LLC · Anesthesiology device
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Aug 2008
Decision
88d
Days
Class 2
Risk

K081516 is an FDA 510(k) clearance for the MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Medsource International, LLC (Mound, US). The FDA issued a Cleared decision on August 26, 2008 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medsource International, LLC devices

Submission Details

510(k) Number K081516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2008
Decision Date August 26, 2008
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 139d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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.