Cleared Traditional

K791445 - TWO-PIECE IPPB MANIFOLD MACHINES

K791445 is the FDA 510(k) clearance for TWO-PIECE IPPB MANIFOLD MACHINES by Airlife, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K791445 · Airlife, Inc. · Anesthesiology device

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Aug 1979

Decision

32d

Days

Class 2

Risk

K791445 is an FDA 510(k) clearance for the TWO-PIECE IPPB MANIFOLD MACHINES. 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 August 28, 1979 after a review of 32 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	K791445 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 1979
Decision Date	August 28, 1979
Days to Decision	32 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

108d faster than avg

Panel avg: 140d · This submission: 32d

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 K791445.

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

K791820 · Airlife, Inc. · Sep 1979

TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE

K791443 · Airlife, Inc. · Aug 1979

UNIVERSAL TWO-PIECE MACHINES

K791444 · Airlife, Inc. · Aug 1979

INHALATION OPERATED NEBULIZER CODE

K791218 · Travenol Laboratories, S.A. · Jul 1979

MISTY NEBULIZER

K790892 · Airlife, Inc. · Jul 1979

SHERWOOD NEBULIZER KIT

K791089 · Sherwood Medical Co. · Jul 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K791445

Airlife, Inc.

Mchenry, IL · US

Regulatory profile

76 submissions 76 cleared

100% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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