Cleared Traditional

K952249 - JET NEBULIZER

K952249 is an FDA 510(k) clearance for JET NEBULIZER, manufactured by Devilbiss Health Care, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K952249 · Devilbiss Health Care, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
260d
Days
Class 2
Risk

K952249 is an FDA 510(k) clearance for the JET NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K952249

510(k) Number K952249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1995
Decision Date January 30, 1996
Days to Decision 260 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 140d · This submission: 260d
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 458
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K952249.
MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
K960397 · Healthline Medical · Apr 1996
DUAL SPRAY MINISPACER
K955805 · Thayer Medical Corp. · Mar 1996
PULMOMIST
K952326 · Global Medical Ent., Inc. · Feb 1996
A&D UN-231 ULTRASONIC HANDY NEBULIZER
K941627 · A & D Corporate · Dec 1995
MEDOX CHAMPION COMPACT NEBULIZER
K954327 · Medox Corp. · Dec 1995
THE SWIRLER AEROSOL SYSTEM
K952893 · Amici, Inc. · Nov 1995
K952249 · JET NEBULIZER
Download PDF FDA Summary Devilbiss Health Care…