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
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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.

View all Cardinalhealth devices

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 223
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K072119.
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K081738 · Health & Life Co., Ltd. · Sep 2008
NEB-U-MASK SYSTEM, MODELS 1895, 1896
K080230 · Teleflexmedical, Inc. · Jun 2008
AMSURE NEBULIZER
K070411 · Amsino International, Inc. · Oct 2007
APEX MEDICAL MOBINEB, 9R-027 SERIES
K070990 · Apex Medical Corp. · May 2007
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · Omron Healthcare, Inc. · Feb 2007
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K053490 · Merits Health Products Co., Ltd. · Jul 2006