Cleared Traditional

K831085 - SYNEVAC VACUUM SOURCE UNIT

K831085 is an FDA 510(k) clearance for SYNEVAC VACUUM SOURCE UNIT, manufactured by Synemed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K831085 · Synemed, Inc. · General & Plastic Surgery device
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Jun 1983
Decision
65d
Days
Class 2
Risk

K831085 is an FDA 510(k) clearance for the SYNEVAC VACUUM SOURCE UNIT. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Synemed, Inc. (Walker, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synemed, Inc. devices

FDA 510(k) Submission Details - K831085

510(k) Number K831085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date June 08, 1983
Days to Decision 65 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
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 104
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K831085.
BRONCHOSCOPE SUCTION UNIT
K841399 · Keymed, Inc. · Jul 1984
EMERGENCY ASPIRATOR
K833785 · Vitalograph , Ltd. · Dec 1983
PSI SURGICAL ASPIRATOR
K832100 · Advanced Biosearch Assn. · Oct 1983
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