Cleared Traditional

VIVASPIN 4 10,000 MW (K960298) - FDA 510(k) Clearance

Class I Chemistry device.

K960298 · Vivascience, Inc. · Chemistry device
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Mar 1996
Decision
57d
Days
Class 1
Risk

K960298 is an FDA 510(k) clearance for the VIVASPIN 4 10,000 MW. 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 March 19, 1996 after a review of 57 days - a notably fast clearance 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: 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 Vivascience, Inc. devices

Submission Details

510(k) Number K960298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date March 19, 1996
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.