Cleared Traditional

K871367 - HY-FLOW NON-REBREATHING VALVE ASSEMBLY

K871367 is an FDA 510(k) clearance for HY-FLOW NON-REBREATHING VALVE ASSEMBLY, manufactured by Med Air Technology, 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.

K871367 · Med Air Technology, Inc. · Anesthesiology device
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Jun 1987
Decision
73d
Days
Class 2
Risk

K871367 is an FDA 510(k) clearance for the HY-FLOW NON-REBREATHING VALVE ASSEMBLY. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Med Air Technology, Inc. (Springfield, US). The FDA issued a Cleared decision on June 19, 1987 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 - K871367

510(k) Number K871367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date June 19, 1987
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.

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 92
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K871367.
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
CARHILL ONE-WAY RESUSCITATION VALVE
K864681 · Life Design Systems, Inc. · May 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
K871367 · HY-FLOW NON-REBREATHING VALVE ASSEMBLY
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