Cleared Traditional

K921611 - MADAVAC 190

K921611 is an FDA 510(k) clearance for MADAVAC 190, manufactured by Mada Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K921611 · Mada Medical Products, Inc. · General & Plastic Surgery device
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Sep 1992
Decision
159d
Days
Class 2
Risk

K921611 is an FDA 510(k) clearance for the MADAVAC 190. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Mada Medical Products, Inc. (Carlstadt, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 159 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 Mada Medical Products, Inc. devices

FDA 510(k) Submission Details - K921611

510(k) Number K921611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1992
Decision Date September 09, 1992
Days to Decision 159 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 115d · This submission: 159d
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 100
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K921611.
PM PUMP ASPIRATOR
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K922176 · Smith & Nephew Dyonics, Inc. · Nov 1992
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VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991
BUNN MODEL 530 ASPIRATOR
K870094 · The John Bunn Co. · Mar 1987
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
K862569 · Jedmed Instrument Co. · Aug 1986