Cleared Traditional

K953461 - CPR MASK & RELATED FAMILY KITS

K953461 is an FDA 510(k) clearance for CPR MASK & RELATED FAMILY KITS, manufactured by Safetec of America, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K953461 · Safetec of America, Inc. · Anesthesiology device
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Jan 1996
Decision
164d
Days
Class 2
Risk

K953461 is an FDA 510(k) clearance for the CPR MASK & RELATED FAMILY KITS. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Safetec of America, Inc. (Buffalo, US). The FDA issued a Cleared decision on January 4, 1996 after a review of 164 days - an extended review 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: 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 Safetec of America, Inc. devices

FDA 510(k) Submission Details - K953461

510(k) Number K953461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1995
Decision Date January 04, 1996
Days to Decision 164 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
24d slower than avg
Panel avg: 140d · This submission: 164d
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 K953461.
CPR MICROMASK WITH OXYGEN INLET
K953414 · Plasco, Inc. · Mar 1996
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
K953349 · Spiracle Technology · Feb 1996
CPR SUPER POCKET PACK
K953230 · Formosa-Cj Health Business Corp. · Feb 1996
CPR MICROMASK
K951483 · Plasco, Inc. · Oct 1995
CPR MICROMASK PLUS CATALOG NO 73-402
K950769 · Plasco, Inc. · Mar 1995
CPR MICROSHIELD II
K950770 · Plasco, Inc. · Mar 1995