Cleared Traditional

K012368 - AEROPEP

K012368 is an FDA 510(k) clearance for AEROPEP, manufactured by Trudell Medical Intl.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K012368 · Trudell Medical Intl. · Anesthesiology device
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Feb 2002
Decision
201d
Days
Class 2
Risk

K012368 is an FDA 510(k) clearance for the AEROPEP. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on February 12, 2002 after a review of 201 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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 - K012368

510(k) Number K012368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date February 12, 2002
Days to Decision 201 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 140d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 - BWF Spirometer, Therapeutic (incentive)

All 79
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K012368.
LIFESTYLE CIRCULATORY ENHANCER
K040084 · Advanced Circulatory Systems, Inc. · Apr 2004
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
K033401 · Advanced Circulatory Systems, Inc. · Nov 2003
RESQPOD CIRCULATORY ENHANCER
K022906 · Cprx, LLC · Jun 2003
ACAPELLA
K002768 · Dhd Healthcare Corp. · Dec 2000
CLINIFLO INCENTIVE SPIROMETER
K003146 · Dhd Healthcare Corp. · Nov 2000
TRI-BALL
K994074 · Leventon, S.A. · Jun 2000