Cleared Traditional

K052458 - LIV MEDICA CPR FACE MASK

K052458 is an FDA 510(k) clearance for LIV MEDICA CPR FACE MASK, manufactured by Liv Medica Products Pvt. , Ltd.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K052458 · Liv Medica Products Pvt. , Ltd. · Anesthesiology device
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Jul 2006
Decision
303d
Days
Class 2
Risk

K052458 is an FDA 510(k) clearance for the LIV MEDICA CPR FACE MASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Liv Medica Products Pvt. , Ltd. (Hockessin, US). The FDA issued a Cleared decision on July 7, 2006 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K052458

510(k) Number K052458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2005
Decision Date July 07, 2006
Days to Decision 303 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 140d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - CBP Valve, Non-rebreathing

All 86
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K052458.
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60
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OXYGEN DEMAND VALVE
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MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
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K052743 · Dynarex Corp. · Dec 2005
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
K042727 · Foremount Ent. Co., Ltd. · Mar 2005
MERLIN E-MASK
K031397 · Merlin Medical Limited · Jul 2004