Cleared Traditional

K940927 - RESCUE BREATHER

K940927 is an FDA 510(k) clearance for RESCUE BREATHER, manufactured by O-Two Systems Intl., Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K940927 · O-Two Systems Intl., Inc. · Anesthesiology device
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Oct 1994
Decision
228d
Days
Class 2
Risk

K940927 is an FDA 510(k) clearance for the RESCUE BREATHER. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by O-Two Systems Intl., Inc. (Mississauga, CA). The FDA issued a Cleared decision on October 14, 1994 after a review of 228 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 O-Two Systems Intl., Inc. devices

FDA 510(k) Submission Details - K940927

510(k) Number K940927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1994
Decision Date October 14, 1994
Days to Decision 228 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
88d slower than avg
Panel avg: 140d · This submission: 228d
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 62
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K940927.
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
K.P.R. (KING PERSONAL RESUSCITATOR)
K943402 · King Systems Corp. · Aug 1994
CPROTECTOR
K934821 · Certified Safety Mfg., Inc. · Jan 1994
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K884543 · Sechrist Industries, Inc. · Dec 1988