Cleared Traditional

K043544 - MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR

K043544 is an FDA 510(k) clearance for MEDELA DOMINANT 35 C/I SECRETION AND SU..., 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 15-day FDA review.

K043544 · Medela AG · General & Plastic Surgery device
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Jan 2005
Decision
15d
Days
Class 2
Risk

K043544 is an FDA 510(k) clearance for the MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR. 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 January 7, 2005 after a review of 15 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

FDA 510(k) Submission Details - K043544

510(k) Number K043544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2004
Decision Date January 07, 2005
Days to Decision 15 days
Submission Type Traditional
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
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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 K043544.
PIONEER U601 SERIES ASPIRATOR
K052650 · Merits Health Products Co., Ltd. · Nov 2005
SMARTSUCTION HARMONY DEVICE
K052626 · Haemonetics Corp. · Oct 2005
PENUMBRA ASPIRATION PUMP, MODEL 115V
K051758 · Penumbra, Inc. · Aug 2005
NOUVAG AG - VACUSON 40 AND VACUSON 60
K042943 · NOUVAG AG · Dec 2004
ASPIRATION PUMP, MODEL IMD-020
K041405 · Industrial & Medical Design, Inc. · Sep 2004
MEDI-PUMP ASPIRATOR, MODEL 1615
K041199 · Thomas Industries · Jun 2004

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.