Cleared Traditional

K941326 - ULTRAFREE-CL (FDA 510(k) Clearance)

Class I Chemistry device.

K941326 · Millipore Corp. · Chemistry device
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May 1994
Decision
70d
Days
Class 1
Risk

K941326 is an FDA 510(k) clearance for the ULTRAFREE-CL. Classified as Clinical Sample Concentrator (product code JJH), Class I - General Controls.

Submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 70 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 Millipore Corp. devices

Submission Details

510(k) Number K941326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date May 27, 1994
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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.