Cleared Traditional

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR (K881931) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881931 · Rondex Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Rondex Products, Inc. devices

Submission Details

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
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.

Device Classification

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

Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K881931.
Altech® Exhalation Valve (Single Limb and Dual Limb)
K210992 · Meditera Tibbi Malzeme San VE Tic AS · Dec 2021
CPR Face Shield
K192285 · Firstar Healthcare Company Limited (Guangzhou) · Nov 2020
OJR215 Pressure Relief Manifold
K173770 · Fisher & Paykel Healthcare Limited · Apr 2019
RESCUE VALVE
K833748 · Respironics, Inc. · Dec 1983