Cleared Abbreviated

K153459 - TACVAC

K153459 is the FDA 510(k) clearance for TACVAC by Athena Gtx. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K153459 · Athena Gtx · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2016
Decision
58d
Days
Class 2
Risk

K153459 is an FDA 510(k) clearance for the TACVAC. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Athena Gtx (Johnson, US). The FDA issued a Cleared decision on January 28, 2016 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 Athena Gtx devices

Submission Details

510(k) Number K153459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2015
Decision Date January 28, 2016
Days to Decision 58 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 43
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K153459.
SOMAVAC Device
K180606 · Somavac Medical Solutions, Inc. · May 2018
Rex Medical Aspiration Pump
K173389 · Rex Medical, L.P. · Jan 2018
Aprima Smartesis Centesis Pump
K161002 · Cook Incorporated · Sep 2016
EDRAIN CHEST DRAINAGE SYSTEM
K130131 · Atrium Medical Corp. · Feb 2013
PENUMBRA ASPIRATION PUMP, MODEL 115V
K051758 · Penumbra, Inc. · Aug 2005
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM
K984363 · Xomed, Inc. · Feb 1999