Cleared Traditional

K790152 - MANIFOLD, UNIVERSAL I.P.P.B

K790152 is an FDA 510(k) clearance for MANIFOLD, manufactured by Airlife, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K790152 · Airlife, Inc. · Anesthesiology device
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Mar 1979
Decision
54d
Days
Class 2
Risk

K790152 is an FDA 510(k) clearance for the MANIFOLD, UNIVERSAL I.P.P.B. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1979 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 - K790152

510(k) Number K790152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1979
Decision Date March 07, 1979
Days to Decision 54 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
86d faster than avg
Panel avg: 140d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 229
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K790152.
NEBULIZER NO. M-175
K790924 · Mem Medical, Inc. · May 1979
NEBULIZER WITH 4-WAY T NO M-174
K790925 · Mem Medical, Inc. · May 1979
NEBULIZER WITH MOUTHPIECE AND TEE
K790926 · Mem Medical, Inc. · May 1979
MANIFOLD, W/CORRUGATED TUBING
K790153 · Airlife, Inc. · Mar 1979
MANIFOLD, FOR DOUBLE SUPPLY
K790154 · Airlife, Inc. · Mar 1979
U-FLOAT VALVE 2D9023
K781467 · Travenol Laboratories, S.A. · Sep 1978