Cleared Traditional

K042943 - NOUVAG AG - VACUSON 40 AND VACUSON 60

K042943 is an FDA 510(k) clearance for NOUVAG AG - VACUSON 40 AND VACUSON 60, manufactured by NOUVAG AG. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K042943 · NOUVAG AG · General & Plastic Surgery device
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Dec 2004
Decision
53d
Days
Class 2
Risk

K042943 is an FDA 510(k) clearance for the NOUVAG AG - VACUSON 40 AND VACUSON 60. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by NOUVAG AG (Gebenstorf, CH). The FDA issued a Cleared decision on December 17, 2004 after a review of 53 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 NOUVAG AG devices

FDA 510(k) Submission Details - K042943

510(k) Number K042943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2004
Decision Date December 17, 2004
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 90
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K042943.
SMARTSUCTION HARMONY DEVICE
K052626 · Haemonetics Corp. · Oct 2005
PENUMBRA ASPIRATION PUMP, MODEL 115V
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K043544 · Medela AG · Jan 2005
MEDELA CLARIO HOME CARE PUMP
K033179 · Medela AG · Oct 2003
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · Medela AG · May 2002
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM
K984363 · Xomed, Inc. · Feb 1999