Cleared Traditional

K832100 - PSI SURGICAL ASPIRATOR

K832100 is an FDA 510(k) clearance for PSI SURGICAL ASPIRATOR, manufactured by Advanced Biosearch Assn.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K832100 · Advanced Biosearch Assn. · General & Plastic Surgery device
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Oct 1983
Decision
97d
Days
Class 2
Risk

K832100 is an FDA 510(k) clearance for the PSI SURGICAL ASPIRATOR. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Advanced Biosearch Assn. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 97 days - within the typical 510(k) review window.

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 Advanced Biosearch Assn. devices

FDA 510(k) Submission Details - K832100

510(k) Number K832100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1983
Decision Date October 04, 1983
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
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 70
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K832100.
PORTASPIR II
K851560 · Roseburg SA · Dec 1985
STORZ ASPIRATION MACHINE SAM 5000
K843644 · Storz Instrument Co. · Nov 1984
BRONCHOSCOPE SUCTION UNIT
K841399 · Keymed, Inc. · Jul 1984
CONNECTING TUBES
K831007 · Medovations, Inc. · May 1983
KEYMED KEY VAC SUCTION PUMP
K820739 · Keymed, Inc. · May 1982
IMPACT, MODELS 306/307
K820338 · Impact Instrumentation, Inc. · Mar 1982