Cleared Traditional

K122480 - INTERNATIONAL BIOPHYSICS CORPORATION AF...

K122480 is an FDA 510(k) clearance for INTERNATIONAL BIOPHYSICS CORPORATION AF..., manufactured by International Biophysics Corporation. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K122480 · International Biophysics Corporation · Anesthesiology device
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Mar 2013
Decision
225d
Days
Class 2
Risk

K122480 is an FDA 510(k) clearance for the INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by International Biophysics Corporation (Austin, US). The FDA issued a Cleared decision on March 27, 2013 after a review of 225 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - 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 International Biophysics Corporation devices

FDA 510(k) Submission Details - K122480

510(k) Number K122480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2012
Decision Date March 27, 2013
Days to Decision 225 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
85d slower than avg
Panel avg: 140d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
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 - BYI Percussor, Powered-electric

All 19
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