Cleared Traditional

K061205 - MEDELA VARIO 8/18/CI SECRETION & SURGIC...

K061205 is the FDA 510(k) clearance for MEDELA VARIO 8/18/CI SECRETION & SURGIC... by Medela AG. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K061205 · Medela AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jun 2006
Decision
51d
Days
Class 2
Risk

K061205 is an FDA 510(k) clearance for the MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on June 21, 2006 after a review of 51 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medela AG devices

Submission Details

510(k) Number K061205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2006
Decision Date June 21, 2006
Days to Decision 51 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K061205.
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
KSEA UNIMAT 45
K981703 · Karl Storz Endoscopy · Aug 1998