Cleared Abbreviated

K033179 - MEDELA CLARIO HOME CARE PUMP

K033179 is an FDA 510(k) clearance for MEDELA CLARIO HOME CARE PUMP, manufactured by Medela AG. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K033179

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
Combination Product No
PCCP Authorized No
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.

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

Tuv America, Inc.
STEFAN PREISS

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 99
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K033179.
ASPIRATION PUMP, MODEL IMD-020
K041405 · Industrial & Medical Design, Inc. · Sep 2004
MEDI-PUMP ASPIRATOR, MODEL 1615
K041199 · Thomas Industries · Jun 2004
S-SCORT...JR QUICKDRAW, MODEL 2400
K041154 · Sscor · May 2004
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · Medela AG · May 2002
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
K993668 · Laerdal Medical A/S · Dec 1999
SORING GMBH, SONOCA 300
K992026 · Soring GmbH Medizintechnik · Sep 1999

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.