Cleared Traditional

K943965 - VIVAPORE 10

K943965 is an FDA 510(k) clearance for VIVAPORE 10, manufactured by Vivascience, Inc.. The device is a Class 1 Chemistry device with product code JJH cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K943965 · Vivascience, Inc. · Chemistry device
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Apr 1995
Decision
257d
Days
Class 1
Risk

K943965 is an FDA 510(k) clearance for the VIVAPORE 10. Classified as Clinical Sample Concentrator (product code JJH), Class I - General Controls.

Submitted by Vivascience, Inc. (Acton, US). The FDA issued a Cleared decision on April 11, 1995 after a review of 257 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2310 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Vivascience, Inc. devices

FDA 510(k) Submission Details - K943965

510(k) Number K943965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date April 11, 1995
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 88d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

JJH Device Classification - Class 1, General Controls

Product Code JJH Clinical Sample Concentrator
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2310
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJH Clinical Sample Concentrator

All 10
Devices cleared under the same product code (JJH) and FDA review panel - the closest regulatory comparables to K943965.
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