Cleared Traditional

K040090 - COMPPAC 200HD

Also marketed or referenced as:
CS12 POWER SUPPLY (AIRCRAFT/VECHILE) PS11 POWER SUPPLY (MAINS)

K040090 is an FDA 510(k) clearance for COMPPAC 200HD, manufactured by Pneupac , Ltd.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K040090 · Pneupac , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
132d
Days
Class 2
Risk

K040090 is an FDA 510(k) clearance for the COMPPAC 200HD. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Pneupac , Ltd. (Waukesha, US). The FDA issued a Cleared decision on May 27, 2004 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Pneupac , Ltd. devices

FDA 510(k) Submission Details - K040090

510(k) Number K040090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2004
Decision Date May 27, 2004
Days to Decision 132 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
8d faster than avg
Panel avg: 140d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 47
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K040090.
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K070210 · Ohmeda Medical · Apr 2007
UNI-VENT MODEL 73X
K051476 · Impact Instrumentation, Inc. · Oct 2005
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
K041473 · Vortran Medical Technology 1, Inc. · Jul 2004
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K032386 · Impact Instrumentation, Inc. · Mar 2004
PARAPAC 200D TRANSPORT, MODEL V200D
K030803 · Pneupac , Ltd. · Sep 2003
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
K021841 · Pneupac , Ltd. · Jul 2003