Cleared Traditional

K921107 - AUTOVAC

K921107 is an FDA 510(k) clearance for AUTOVAC, manufactured by Life Support 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 192-day FDA review.

K921107 · Life Support Products, Inc. · General & Plastic Surgery device
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Sep 1992
Decision
192d
Days
Class 2
Risk

K921107 is an FDA 510(k) clearance for the AUTOVAC. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 192 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 Life Support Products, Inc. devices

FDA 510(k) Submission Details - K921107

510(k) Number K921107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date September 17, 1992
Days to Decision 192 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 115d · This submission: 192d
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 81
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K921107.
BATTERY PACK #1005NC
K931348 · Portable Power Systems, Inc. · Feb 1994
PM PUMP ASPIRATOR
K932494 · Precision Medical, Inc. · Oct 1993
INTELIJET SUCTION SUPPLY
K922176 · Smith & Nephew Dyonics, Inc. · Nov 1992
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