Cleared Traditional

K832868 - RESUSCITATION VALVE

K832868 is the FDA 510(k) clearance for RESUSCITATION VALVE by Boehringer Laboratories. It is a Class 2 Anesthesiology device (product code CBP) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K832868 · Boehringer Laboratories · Anesthesiology device
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Sep 1983
Decision
33d
Days
Class 2
Risk

K832868 is an FDA 510(k) clearance for the RESUSCITATION VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Boehringer Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 33 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 Boehringer Laboratories devices

Submission Details

510(k) Number K832868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1983
Decision Date September 26, 1983
Days to Decision 33 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 140d · This submission: 33d
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

All 9
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K832868.
OJR215 Pressure Relief Manifold
K173770 · Fisher & Paykel Healthcare Limited · Apr 2019
PRESSURE MANIFOLD, MODEL BC 110
K040366 · Fisher &Paykel Healthcare , Ltd. · Mar 2004
RESCUE VALVE
K833748 · Respironics, Inc. · Dec 1983
WHISTLER IN-LINE PRESSURE RELEASE VALVE
K831246 · Airlife, Inc. · Jul 1983
ONE-WAY VALVE
K790151 · Airlife, Inc. · Mar 1979