Cleared Traditional

K883383 - LIFEGUARD VENT MASK

K883383 is an FDA 510(k) clearance for LIFEGUARD VENT MASK, manufactured by Breath of Life, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K883383 · Breath of Life, Inc. · Anesthesiology device
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Nov 1988
Decision
104d
Days
Class 2
Risk

K883383 is an FDA 510(k) clearance for the LIFEGUARD VENT MASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Breath of Life, Inc. (Flushing, US). The FDA issued a Cleared decision on November 21, 1988 after a review of 104 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K883383

510(k) Number K883383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date November 21, 1988
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
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 92
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K883383.
MAGNASHIELD CPR MOUTH BARRIER
K933756 · Cal West Trading Co. · Jan 1994
CPR VALVE (NON-REBREATHING) MODEL #9030
K902299 · Rondex Products, Inc. · Oct 1990
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K884543 · Sechrist Industries, Inc. · Dec 1988
NON-REBREATHING TEE PIECE (NRTP)
K883988 · Dhd Medical Products Div. Diemolding Corp. · Oct 1988
LIFECARE EXHALATION VALVE #06-699
K873570 · Lifecare Services, Inc. · Nov 1987
CARHILL ONE-WAY RESUSCITATION VALVE
K864681 · Life Design Systems, Inc. · May 1987
K883383 · LIFEGUARD VENT MASK
Download PDF Breath of Life, Inc.