Cleared Traditional

K183108 - Combined Aerobika OPEP and VersaPAP device (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183108 · Trudell Medical International · Anesthesiology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 139d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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All 107
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