Cleared Abbreviated

K033179 - MEDELA CLARIO HOME CARE PUMP

K033179 is the FDA 510(k) clearance for MEDELA CLARIO HOME CARE PUMP by Medela AG. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Abbreviated 510(k) pathway after a 14-day FDA review.

K033179 · Medela AG · General & Plastic Surgery device
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Oct 2003
Decision
14d
Days
Class 2
Risk

K033179 is an FDA 510(k) clearance for the MEDELA CLARIO HOME CARE PUMP. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Medela AG (Ch-6340 Baar, CH). The FDA issued a Cleared decision on October 15, 2003 after a review of 14 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 Medela AG devices

Submission Details

510(k) Number K033179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2003
Decision Date October 15, 2003
Days to Decision 14 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 K033179.
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