510(k) Report

FDA applicant

Ihara Medics U.S., Inc.

Valencia, CA5 decisions1990–19960 recalls

FDA records 5 decisions for Ihara Medics U.S., Inc. (Valencia, CA) from 1990 to 1996: 5 510(k) clearances. Most are in product codes JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)) and JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.)…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Ihara Medics U.S., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ihara Medics U.S., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ihara Medics U.S., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JINNitroprusside, Ketones (Urinary, Non-Quant.)4decisions
  • JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase1decision

What has FDA decided for it lately?

  • K953452Ketorex C SanwaIhara Medics U.S., Inc. · 1996
  • K912373Keto-340 IIIhara Medics U.S., Inc. · 1991
  • K903365Ketorex Sanwa StandardsIhara Medics U.S., Inc. · 1990
  • K903367Ketone Test a Sanwa StandardIhara Medics U.S., Inc. · 1990
  • K903366Ketone Test B Sanwa StandardIhara Medics U.S., Inc. · 1990

All 5 as Ihara Medics U.S., Inc. →