Cleared Traditional

K072119 - AIRLIFE NEBULIZER CAP

K072119 is an FDA 510(k) clearance for AIRLIFE NEBULIZER CAP, manufactured by Cardinalhealth. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K072119 · Cardinalhealth · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
9d
Days
Class 2
Risk

K072119 is an FDA 510(k) clearance for the AIRLIFE NEBULIZER CAP. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on August 10, 2007 after a review of 9 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.

FDA 510(k) Submission Details - K072119

510(k) Number K072119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date August 10, 2007
Days to Decision 9 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 140d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED LEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K072119.
AKITA2 APIXNEB
K072019 · Activaero America, Inc. · Nov 2007
AMSURE NEBULIZER
K070411 · Amsino International, Inc. · Oct 2007
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
K072418 · Respironics New Jersey, Inc. · Sep 2007
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
K062484 · Flaem Nuova S.P.A. · Jun 2007
APEX MEDICAL MOBINEB, 9R-027 SERIES
K070990 · Apex Medical Corp. · May 2007
AERONEB PROFESSIONAL NEBULIZER SYSTEM
K070642 · Aerogen (Ireland), Ltd. · May 2007