Cleared Traditional

K925011 - NEBULIZER PUMP, POWERED MODEL 1180

K925011 is an FDA 510(k) clearance for NEBULIZER PUMP, manufactured by Thomas Industries. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K925011 · Thomas Industries · Anesthesiology device
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Jan 1994
Decision
467d
Days
Class 2
Risk

K925011 is an FDA 510(k) clearance for the NEBULIZER PUMP, POWERED MODEL 1180. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Thomas Industries (Sheboygan, US). The FDA issued a Cleared decision on January 12, 1994 after a review of 467 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Thomas Industries devices

FDA 510(k) Submission Details - K925011

510(k) Number K925011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date January 12, 1994
Days to Decision 467 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 140d · This submission: 467d
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 31
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K925011.
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
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
K931015 · Devilbiss Health Care, Inc. · Sep 1993
SAM ST
K913097 · Ferguson Medical · Dec 1992
NEBULIZER SYSTEM
K922623 · Healthdyne, Inc. · Dec 1992