Cleared Traditional

K881931 - RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR

K881931 is an FDA 510(k) clearance for RESCUE MASK & CPR VALVE FOR MOUTH-TO-MA..., manufactured by Rondex Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K881931 · Rondex Products, Inc. · Anesthesiology device
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Jul 1988
Decision
73d
Days
Class 2
Risk

K881931 is an FDA 510(k) clearance for the RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Rondex Products, Inc. (Rockford, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K881931

510(k) Number K881931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1988
Decision Date July 21, 1988
Days to Decision 73 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 140d · This submission: 73d
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 102
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K881931.
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K884543 · Sechrist Industries, Inc. · Dec 1988
LIFEGUARD VENT MASK
K883383 · Breath of Life, Inc. · Nov 1988
NON-REBREATHING TEE PIECE (NRTP)
K883988 · Dhd Medical Products Div. Diemolding Corp. · Oct 1988
RESUSCITATOR VALVE ASSEMBLY W/FILTER
K882204 · Intertech/Ohio · Jul 1988
LIFECARE EXHALATION VALVE #06-699
K873570 · Lifecare Services, Inc. · Nov 1987
HY-FLOW NON-REBREATHING VALVE ASSEMBLY
K871367 · Med Air Technology, Inc. · Jun 1987
K881931 · RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR
Download PDF Rondex Products, Inc.