Cleared Traditional

K040239 - SUPRAFLOW CONSOLE

K040239 is an FDA 510(k) clearance for SUPRAFLOW CONSOLE, manufactured by Neomedix Corp.. 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.

K040239 · Neomedix Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
15d
Days
Class 2
Risk

K040239 is an FDA 510(k) clearance for the SUPRAFLOW CONSOLE. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Neomedix Corp. (San Juan Capistrano, US). The FDA issued a Cleared decision on February 17, 2004 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 Neomedix Corp. devices

FDA 510(k) Submission Details - K040239

510(k) Number K040239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date February 17, 2004
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.

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 93
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K040239.
SMARTSUCTION HARMONY DEVICE
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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