Cleared Traditional

K153663 - Vario 8/18/ci

K153663 is an FDA 510(k) clearance for Vario 8/18/ci, manufactured by Medela AG. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K153663 · Medela AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
149d
Days
Class 2
Risk

K153663 is an FDA 510(k) clearance for the Vario 8/18/ci. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Medela AG (Baar, CH). The FDA issued a Cleared decision on May 18, 2016 after a review of 149 days - within the typical 510(k) review window.

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 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medela AG devices

FDA 510(k) Submission Details - K153663

510(k) Number K153663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date May 18, 2016
Days to Decision 149 days
Submission Type Traditional
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
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Pathway Regulatory Consulting, LLC
ADRIENNE LENZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 100
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K153663.
Rex Medical Aspiration Pump
K173389 · Rex Medical, L.P. · Jan 2018
Model 330 Multifunction Aspirator
K170533 · ZOLL Medical Corporation · Apr 2017
Aprima Smartesis Centesis Pump
K161002 · Cook Incorporated · Sep 2016
TACVAC
K153459 · Athena Gtx · Jan 2016
SIMEX SUBGLOTTIC ASPIRATION SYSTEM
K141255 · Simex Medizintechnik GmbH · Sep 2014
MEDELA THOPAZ+
K141553 · Medela AG · Aug 2014