Cleared Traditional

K081516 - MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT

K081516 is an FDA 510(k) clearance for MEDSOURCE CPR MASK WITH & WITHOUT OXYGE..., manufactured by Medsource International, LLC. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

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

FDA 510(k) Submission Details - K081516

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

CBP Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CBP Valve, Non-rebreathing

All 70
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K081516.
CPR MASK
K083418 · Firstar Healthcare Co., Ltd. · Jul 2010
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60
K091538 · Wet Nose Technologies, LLC · Mar 2010
OXYGEN DEMAND VALVE
K082345 · Bpr Medical, Ltd. · Mar 2009
LIV MEDICA CPR FACE MASK
K052458 · Liv Medica Products Pvt. , Ltd. · Jul 2006
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
K052743 · Dynarex Corp. · Dec 2005
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
K042727 · Foremount Ent. Co., Ltd. · Mar 2005