Cleared Traditional

K955520 - RESCUE BREATHER

K955520 is an FDA 510(k) clearance for RESCUE BREATHER, manufactured by International Safety, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K955520 · International Safety, Inc. · Anesthesiology device
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Oct 1996
Decision
309d
Days
Class 2
Risk

K955520 is an FDA 510(k) clearance for the RESCUE BREATHER. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by International Safety, Inc. (Eugene, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 309 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 International Safety, Inc. devices

FDA 510(k) Submission Details - K955520

510(k) Number K955520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date October 08, 1996
Days to Decision 309 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 140d · This submission: 309d
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 K955520.
CPROTECTOR 2000
K960587 · Certified Safety Mfg., Inc. · Jul 1997
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
K963755 · Spiracle Technology · Apr 1997
CPR BIO-BARRIER FACESHEILD
K960995 · O-Two Systems Intl., Inc. · Jan 1997
CPR LIFE MASK COMPACT BARRIER
K954426 · Carefree Trading, Inc. · Sep 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · Boston Medical Products, Inc. · Jun 1996
CPR MICROMASK WITH OXYGEN INLET
K953414 · Plasco, Inc. · Mar 1996