Cleared Traditional

K941961 - 605 VACU-MAX

K941961 is an FDA 510(k) clearance for 605 VACU-MAX, manufactured by Medical Industries America, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K941961 · Medical Industries America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
314d
Days
Class 2
Risk

K941961 is an FDA 510(k) clearance for the 605 VACU-MAX. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Medical Industries America, Inc. (Adel, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medical Industries America, Inc. devices

FDA 510(k) Submission Details - K941961

510(k) Number K941961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date March 02, 1995
Days to Decision 314 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
199d slower than avg
Panel avg: 115d · This submission: 314d
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 76
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K941961.
UIMAT PUMP
K953132 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
AMBU PORTABLE SUCTION UNIT
K932031 · Ambu, Inc. · May 1995
ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
K951423 · Impact Instrumentation, Inc. · Apr 1995
ELECTRIC VACUM PUMP
K941096 · Impact Instrumentation, Inc. · Jan 1995
COOK ASPIRATION/IRRIGATION UNIT
K944818 · Cook Urological, Inc. · Nov 1994
R&D BATTERIES, PART NOS. 5243, 5104, AND 5481
K942033 · R & D Batteries, Inc. · Jun 1994