Cleared Traditional

K954426 - CPR LIFE MASK COMPACT BARRIER

K954426 is an FDA 510(k) clearance for CPR LIFE MASK COMPACT BARRIER, manufactured by Carefree Trading, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K954426 · Carefree Trading, Inc. · Anesthesiology device
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Sep 1996
Decision
360d
Days
Class 2
Risk

K954426 is an FDA 510(k) clearance for the CPR LIFE MASK COMPACT BARRIER. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Carefree Trading, Inc. (Phoenix, US). The FDA issued a Cleared decision on September 16, 1996 after a review of 360 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.

View all Carefree Trading, Inc. devices

FDA 510(k) Submission Details - K954426

510(k) Number K954426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 22, 1995
Decision Date September 16, 1996
Days to Decision 360 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
220d slower than avg
Panel avg: 140d · This submission: 360d
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 61
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K954426.
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
K963755 · Spiracle Technology · Apr 1997
CPR BIO-BARRIER FACESHEILD
K960995 · O-Two Systems Intl., Inc. · Jan 1997
RESCUE BREATHER
K955520 · International Safety, Inc. · Oct 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · Boston Medical Products, Inc. · Jun 1996
CPR MICROMASK WITH OXYGEN INLET
K953414 · Plasco, Inc. · Mar 1996
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
K953349 · Spiracle Technology · Feb 1996