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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 458
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K946095.
MARSAM MODEL 2000 NEBULIZER
K933961 · Marsam Pharmaceuticals, Inc. · Sep 1995
MASTER-NEB NEBULIZER COMPRESSOR SYSTEM
K943717 · Howard K. Mann & Assoc. · Sep 1995
DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
K953206 · Dhd Diemolding Healthcare Div. · Aug 1995
MEDI - PUMP
K950290 · Thomas Industries · Aug 1995
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300
K951259 · Impulso Trading Co. · Jun 1995
MEDI - PUMP
K950867 · Thomas Industries · Apr 1995
K946095 · DEVILBISS MODEL 5500
Download PDF FDA Summary Devilbiss Health Care…