Cleared Traditional

K790151 - ONE-WAY VALVE

K790151 is an FDA 510(k) clearance for ONE-WAY VALVE, manufactured by Airlife, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K790151 · Airlife, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1979
Decision
59d
Days
Class 2
Risk

K790151 is an FDA 510(k) clearance for the ONE-WAY VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1979 after a review of 59 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 Airlife, Inc. devices

FDA 510(k) Submission Details - K790151

510(k) Number K790151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1979
Decision Date March 12, 1979
Days to Decision 59 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
81d faster than avg
Panel avg: 140d · This submission: 59d
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 K790151.
ONE-WAY VALVE-MALE, M-504
K791849 · Mem Medical, Inc. · Oct 1979
ONE-WAY VALVE-FEMALE, M-503
K791850 · Mem Medical, Inc. · Oct 1979
NON-REBREATHING T PIECE
K790820 · Dhd Medical Products Div. Diemolding Corp. · May 1979
VALVE, VENT-AWAY TWO-WAY
K781920 · Chesebrough-Pond'S U.S.A. Co. · Dec 1978
ADAPTER, VALVE, ONE WAY BE-130-22
K770627 · Instrumentation Industries, Inc. · May 1977
VALVE, EXHALATION BE 115-4, 115-5
K770629 · Instrumentation Industries, Inc. · May 1977