Cleared Traditional

K864681 - CARHILL ONE-WAY RESUSCITATION VALVE

K864681 is the FDA 510(k) clearance for CARHILL ONE-WAY RESUSCITATION VALVE by Life Design Systems, Inc.. It is a Class 2 Anesthesiology device (product code CBP) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K864681 · Life Design Systems, Inc. · Anesthesiology device
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May 1987
Decision
170d
Days
Class 2
Risk

K864681 is an FDA 510(k) clearance for the CARHILL ONE-WAY RESUSCITATION VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 21, 1987 after a review of 170 days - an extended review 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: 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.

View all Life Design Systems, Inc. devices

Submission Details

510(k) Number K864681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date May 21, 1987
Days to Decision 170 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 140d · This submission: 170d
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 K864681.
CPR Face Shield
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OJR215 Pressure Relief Manifold
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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