Cleared Abbreviated

K133981 - AVACEN 100 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K133981 · Avacen, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
232d
Days
Class 2
Risk

K133981 is an FDA 510(k) clearance for the AVACEN 100. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Avacen, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 2014 after a review of 232 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Avacen, Inc. devices

Submission Details

510(k) Number K133981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date August 15, 2014
Days to Decision 232 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
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 Physical Medicine devices follow this clearance model.