Cleared Traditional

K931015 - DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER

K931015 is an FDA 510(k) clearance for DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER, manufactured by Devilbiss Health Care, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K931015 · Devilbiss Health Care, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
216d
Days
Class 2
Risk

K931015 is an FDA 510(k) clearance for the DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on September 30, 1993 after a review of 216 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 - K931015

510(k) Number K931015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1993
Decision Date September 30, 1993
Days to Decision 216 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
76d slower than avg
Panel avg: 140d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 30
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K931015.
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997
503 MAXI COMPRESSOR
K940630 · Medical Industries America, Inc. · Feb 1995
PM PUMP COMPRESSOR
K930509 · Precision Medical, Inc. · Oct 1994
SAM ST
K913097 · Ferguson Medical · Dec 1992
NEBULIZER SYSTEM
K922623 · Healthdyne, Inc. · Dec 1992
AIR STAR
K920954 · Infrasonics Corp. · Aug 1992