Cleared Traditional

KETOREX C SANWA (K953452) - FDA 510(k) Clearance

Class I Chemistry device.

K953452 · Ihara Medics U.S., Inc. · Chemistry device
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May 1996
Decision
289d
Days
Class 1
Risk

K953452 is an FDA 510(k) clearance for the KETOREX C SANWA. Classified as Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase (product code JMK), Class I - General Controls.

Submitted by Ihara Medics U.S., Inc. (Valencia, US). The FDA issued a Cleared decision on May 2, 1996 after a review of 289 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1380 - 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 Ihara Medics U.S., Inc. devices

Submission Details

510(k) Number K953452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1995
Decision Date May 02, 1996
Days to Decision 289 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
201d slower than avg
Panel avg: 88d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JMK Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1380
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.