Cleared Special

K150173 - Aerobika OPEP Devive with Manometer

K150173 is an FDA 510(k) clearance for Aerobika OPEP Devive with Manometer, manufactured by Trudell Medical International. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Special 510(k) pathway after a 262-day FDA review.

K150173 · Trudell Medical International · Anesthesiology device
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Oct 2015
Decision
262d
Days
Class 2
Risk

K150173 is an FDA 510(k) clearance for the Aerobika OPEP Devive with Manometer. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on October 15, 2015 after a review of 262 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Trudell Medical International devices

FDA 510(k) Submission Details - K150173

510(k) Number K150173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2015
Decision Date October 15, 2015
Days to Decision 262 days
Submission Type Special
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
122d slower than avg
Panel avg: 140d · This submission: 262d
Pathway characteristics
Modification to existing cleared device.

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 76
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K150173.
iPEP System and vPEP
K160636 · D R Burton Healthcare, LLC · Aug 2016
O-PEP
K150044 · Pari Respiratory Equipment, Inc. · May 2016
VibraPEP
K153441 · Medica Holdings, LLC · Mar 2016
AEROSURE MEDIC
K140772 · Actegy , Ltd. · Dec 2014
VOLUMETRIC INCENTIVE SPIROMETER
K141355 · Besmed Health Business Corporation · Sep 2014
TRIBALL INCENTIVE SPIROMETER
K133873 · Besmed Health Business Corp · Apr 2014