Cleared Traditional

K960397 - MEDICATOR AEROSOL DRUG DELIVERY SYSTEM

K960397 is an FDA 510(k) clearance for MEDICATOR AEROSOL DRUG DELIVERY SYSTEM, manufactured by Healthline Medical. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K960397 · Healthline Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
88d
Days
Class 2
Risk

K960397 is an FDA 510(k) clearance for the MEDICATOR AEROSOL DRUG DELIVERY SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Healthline Medical (Baldwin Park, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 88 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 Healthline Medical devices

FDA 510(k) Submission Details - K960397

510(k) Number K960397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date April 26, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
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 349
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K960397.
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K961476 · Salter Labs · Jul 1996
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
K955104 · Automatic Liquid Packaging, Inc. · Jun 1996
WALKHALER PORTABLE COMPRESSOR MODEL 45F70
K960675 · Pari Holding Co. · May 1996
DUAL SPRAY MINISPACER
K955805 · Thayer Medical Corp. · Mar 1996
PULMOMIST
K952326 · Global Medical Ent., Inc. · Feb 1996
JET NEBULIZER
K952249 · Devilbiss Health Care, Inc. · Jan 1996