Cleared Traditional

K864681 - CARHILL ONE-WAY RESUSCITATION VALVE

K864681 is an FDA 510(k) clearance for CARHILL ONE-WAY RESUSCITATION VALVE, manufactured by Life Design Systems, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K864681

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
Combination Product No
PCCP Authorized No
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.

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 44
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K864681.
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
NO. 1552, VALVED VENTI-COMP
K870895 · Hudson Oxygen Therapy Sales Co. · May 1987
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
K870138 · Hudson Oxygen Therapy Sales Co. · Mar 1987
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
K870253 · Intertech Resources, Inc. · Mar 1987