Cleared Traditional

K093241 - V7 PORTABLE SUCTION UNITS

K093241 is an FDA 510(k) clearance for V7 PORTABLE SUCTION UNITS, manufactured by Hersill, S.L.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K093241 · Hersill, S.L. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
194d
Days
Class 2
Risk

K093241 is an FDA 510(k) clearance for the V7 PORTABLE SUCTION UNITS. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Hersill, S.L. (Mostoles ( Madrid), ES). The FDA issued a Cleared decision on April 27, 2010 after a review of 194 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hersill, S.L. devices

FDA 510(k) Submission Details - K093241

510(k) Number K093241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2009
Decision Date April 27, 2010
Days to Decision 194 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
79d slower than avg
Panel avg: 115d · This submission: 194d
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 78
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