Cleared Special

K141553 - MEDELA THOPAZ+

K141553 is an FDA 510(k) clearance for MEDELA THOPAZ+, manufactured by Medela AG. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Special 510(k) pathway after a 75-day FDA review.

K141553 · Medela AG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
75d
Days
Class 2
Risk

K141553 is an FDA 510(k) clearance for the MEDELA THOPAZ+. 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 August 25, 2014 after a review of 75 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141553

510(k) Number K141553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2014
Decision Date August 25, 2014
Days to Decision 75 days
Submission Type Special
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
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

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 159
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K141553.
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K130123 · Medela AG · Oct 2013
MEDELA THOPAZ
K130210 · Medela AG · Mar 2013
K141553 · MEDELA THOPAZ+
Download PDF FDA Summary Medela AG