Cleared Traditional

K923888 - DEVILBISS MODEL 5650 PULMO-AIDE

K923888 is an FDA 510(k) clearance for DEVILBISS MODEL 5650 PULMO-AIDE, 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 203-day FDA review.

K923888 · Devilbiss Health Care, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
203d
Days
Class 2
Risk

K923888 is an FDA 510(k) clearance for the DEVILBISS MODEL 5650 PULMO-AIDE. 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 February 23, 1993 after a review of 203 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 - K923888

510(k) Number K923888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date February 23, 1993
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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 457
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K923888.
SOFT-MIST(TM)
K924649 · Vortran Medical Technology 1, Inc. · May 1993
MILLIPORE RT-100 AEROSOL RETENTION FILTER
K931603 · Sterimatics Co. · May 1993
THAYER HAND HELD M.K.I. HOLDING CHAMBER
K924535 · Thayer Medical Corp. · Mar 1993
BETAMIST 2
K923698 · Rantran, Inc. · Feb 1993
THE MILLER NEBULIZER SYSTEM
K926055 · Warren C. Miller · Feb 1993
PRECISION MIST COMPRESSOR
K923324 · Precision Medical, Inc. · Jan 1993
K923888 · DEVILBISS MODEL 5650 PULMO-AIDE
Download PDF FDA Summary Devilbiss Health Care…