Cleared Traditional

K043544 - MEDELA DOMINANT 35 C/I SECRETION AND SU...

K043544 is the FDA 510(k) clearance for MEDELA DOMINANT 35 C/I SECRETION AND SU... by Medela AG. It is a Class 2 General & Plastic Surgery device (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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Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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
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