Cleared Traditional

K791820 - I.P.P.B. MANIFOLDS & NEB. SING. & DBL

K791820 is the FDA 510(k) clearance for I.P.P.B. MANIFOLDS & NEB. SING. & DBL by Airlife, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K791820 · Airlife, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
12d
Days
Class 2
Risk

K791820 is an FDA 510(k) clearance for the I.P.P.B. MANIFOLDS & NEB. SING. & DBL. 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 September 26, 1979 after a review of 12 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

Submission Details

510(k) Number K791820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date September 26, 1979
Days to Decision 12 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
128d faster than avg
Panel avg: 140d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 93
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K791820.
NEBULIZER TUBING SET
K800083 · Abbott Laboratories · Jan 1980
TEE ADAPTER
K792364 · Airlife, Inc. · Dec 1979
MISTY BEBULIZER
K792218 · Airlife, Inc. · Nov 1979
TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE
K791443 · Airlife, Inc. · Aug 1979
UNIVERSAL TWO-PIECE MACHINES
K791444 · Airlife, Inc. · Aug 1979
TWO-PIECE IPPB MANIFOLD MACHINES
K791445 · Airlife, Inc. · Aug 1979