510(k) Report

FDA applicant

Nishitomo Co., Inc.

Japan, JP2 decisions1990–20030 recalls

FDA records 2 decisions for Nishitomo Co., Inc. (Japan, JP) from 1990 to 2003: 2 510(k) clearances. All are in product code LHD (Device, Fertility Diagnostic, Proceptive). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Nishitomo Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nishitomo Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nishitomo Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LHDDevice, Fertility Diagnostic, Proceptive2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K901512L SophiaNishitomo Co., Inc. · 19901cites it
  • K021978Petit SophiaNishitomo Co., Inc. · 20031cites it

What has FDA decided for it lately?

  • K021978Petit SophiaNishitomo Co., Inc. · 2003
  • K901512L SophiaNishitomo Co., Inc. · 1990

All 2 as Nishitomo Co., Inc. →