Cleared Traditional

K940503 - MOUTH-TO-MASK RESUSCITATOR

K940503 is an FDA 510(k) clearance for MOUTH-TO-MASK RESUSCITATOR, manufactured by Mtm Health Products , Ltd.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K940503 · Mtm Health Products , Ltd. · Anesthesiology device
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Mar 1995
Decision
413d
Days
Class 2
Risk

K940503 is an FDA 510(k) clearance for the MOUTH-TO-MASK RESUSCITATOR. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Mtm Health Products , Ltd. (L7r 2e3, CA). The FDA issued a Cleared decision on March 23, 1995 after a review of 413 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Mtm Health Products , Ltd. devices

FDA 510(k) Submission Details - K940503

510(k) Number K940503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1994
Decision Date March 23, 1995
Days to Decision 413 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 140d · This submission: 413d
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 72
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K940503.
CPR SUPER POCKET PACK
K953230 · Formosa-Cj Health Business Corp. · Feb 1996
CPR MASK & RELATED FAMILY KITS
K953461 · Safetec of America, Inc. · Jan 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
CPR MICROMASK
K943386 · Plasco, Inc. · Feb 1995