Cleared Traditional

K960995 - CPR BIO-BARRIER FACESHEILD

K960995 is an FDA 510(k) clearance for CPR BIO-BARRIER FACESHEILD, 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 301-day FDA review.

K960995 · O-Two Systems Intl., Inc. · Anesthesiology device
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Jan 1997
Decision
301d
Days
Class 2
Risk

K960995 is an FDA 510(k) clearance for the CPR BIO-BARRIER FACESHEILD. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by O-Two Systems Intl., Inc. (Ontario L5s 1c8, CA). The FDA issued a Cleared decision on January 7, 1997 after a review of 301 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 O-Two Systems Intl., Inc. devices

FDA 510(k) Submission Details - K960995

510(k) Number K960995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1996
Decision Date January 07, 1997
Days to Decision 301 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
161d slower than avg
Panel avg: 140d · This submission: 301d
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 K960995.
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · Instrumentation Industries, Inc. · Sep 1997
CPROTECTOR 2000
K960587 · Certified Safety Mfg., Inc. · Jul 1997
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
K963755 · Spiracle Technology · Apr 1997
RESCUE BREATHER
K955520 · International Safety, Inc. · Oct 1996
CPR LIFE MASK COMPACT BARRIER
K954426 · Carefree Trading, Inc. · Sep 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · Boston Medical Products, Inc. · Jun 1996