Cleared Traditional

K183108 - Combined Aerobika OPEP and VersaPAP device

K183108 is an FDA 510(k) clearance for Combined Aerobika OPEP and VersaPAP device, manufactured by Trudell Medical International. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K183108 · Trudell Medical International · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
281d
Days
Class 2
Risk

K183108 is an FDA 510(k) clearance for the Combined Aerobika OPEP and VersaPAP device. 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 August 16, 2019 after a review of 281 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.

View all Trudell Medical International devices

FDA 510(k) Submission Details - K183108

510(k) Number K183108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2018
Decision Date August 16, 2019
Days to Decision 281 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
141d slower than avg
Panel avg: 140d · This submission: 281d
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 36
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K183108.
Pulsehaler
K203378 · Respinova, Ltd. · Mar 2021
D R Burton OxyPAP
K192000 · D R Burton Healthcare, LLC · Feb 2020
Acapella Choice Blue Vibratory PEP Device
K181660 · Smiths Medical · Oct 2019
Hudson RCI Voldyne Volumetric Exerciser
K182847 · Teleflexmedical, Inc. · Jul 2019
VersaPAP Positive Airway Pressure (PAP) Device
K173918 · Trudell Medical International · Aug 2018
VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999