Cleared Traditional

K041781 - VENTILAIR II MEDICAL AIR COMPRESSOR

K041781 is an FDA 510(k) clearance for VENTILAIR II MEDICAL AIR COMPRESSOR, manufactured by Hamilton Medical AG. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K041781 · Hamilton Medical AG · Anesthesiology device
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Mar 2005
Decision
256d
Days
Class 2
Risk

K041781 is an FDA 510(k) clearance for the VENTILAIR II MEDICAL AIR COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Hamilton Medical AG (Reno, US). The FDA issued a Cleared decision on March 14, 2005 after a review of 256 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 Hamilton Medical AG devices

FDA 510(k) Submission Details - K041781

510(k) Number K041781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2004
Decision Date March 14, 2005
Days to Decision 256 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
116d slower than avg
Panel avg: 140d · This submission: 256d
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 29
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K041781.
MINIMATE COMPRESSOR
K051691 · Precision Medical, Inc. · Dec 2005
AEROMIST LT, MODEL HCS15004
K031686 · Medline Industries, Inc. · Jan 2004
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
K023354 · Siemens Elema AB · Sep 2003
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K982789 · Drager, Inc. · Oct 1998
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997
503 MAXI COMPRESSOR
K940630 · Medical Industries America, Inc. · Feb 1995