Cleared Traditional

K934976 - INSTAVAC II

K934976 is an FDA 510(k) clearance for INSTAVAC II, manufactured by Aeros Instruments, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K934976 · Aeros Instruments, Inc. · General & Plastic Surgery device
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May 1994
Decision
195d
Days
Class 2
Risk

K934976 is an FDA 510(k) clearance for the INSTAVAC II. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Aeros Instruments, Inc. (Northbrook, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 195 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 Aeros Instruments, Inc. devices

FDA 510(k) Submission Details - K934976

510(k) Number K934976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date May 02, 1994
Days to Decision 195 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
80d slower than avg
Panel avg: 115d · This submission: 195d
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 108
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K934976.
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
LIFE VAC
K940934 · Life Support Products, Inc. · May 1994
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