Cleared Traditional

K946095 - DEVILBISS MODEL 5500

K946095 is an FDA 510(k) clearance for DEVILBISS MODEL 5500, 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 253-day FDA review.

K946095 · Devilbiss Health Care, Inc. · Anesthesiology device
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Aug 1995
Decision
253d
Days
Class 2
Risk

K946095 is an FDA 510(k) clearance for the DEVILBISS MODEL 5500. 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 August 24, 1995 after a review of 253 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.

View all Devilbiss Health Care, Inc. devices

FDA 510(k) Submission Details - K946095

510(k) Number K946095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1994
Decision Date August 24, 1995
Days to Decision 253 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
113d slower than avg
Panel avg: 140d · This submission: 253d
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 229
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K946095.
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
JET NEBULIZER
K952249 · Devilbiss Health Care, Inc. · Jan 1996
3000 AEROSOL TWO
K943990 · Medical Industries America, Inc. · Mar 1995
AIRSEP NEWLIFE AIR OUTLET OPTION
K944020 · Airsep Corp. · Mar 1995
3002 AEROMAX
K942444 · Medical Industries America, Inc. · Mar 1995