Cleared Abbreviated

K153459 - TACVAC

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

K153459 · Athena Gtx · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K153459

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

BTA Device Classification - Class 2, Special Controls

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 99
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K153459.
Model 330 Multifunction Aspirator
K170533 · ZOLL Medical Corporation · Apr 2017
Aprima Smartesis Centesis Pump
K161002 · Cook Incorporated · Sep 2016
Vario 8/18/ci
K153663 · Medela AG · May 2016
SIMEX SUBGLOTTIC ASPIRATION SYSTEM
K141255 · Simex Medizintechnik GmbH · Sep 2014
MEDELA THOPAZ+
K141553 · Medela AG · Aug 2014
EASY GO VAC
K140179 · Precision Medical, Inc. · Apr 2014