510(k) Report

FDA applicant

Colin Corp.

Komaki City, Aichi Pref., JP1 decision2002–20020 recalls

FDA records 1 decision for Colin Corp. (Komaki City, Aichi Pref., JP) in 2002: 1 510(k) clearance. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 5 predicates, 0 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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Colin Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Colin Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K013434VP-2000/1000Colin Corp. · 20027cite it

What has FDA decided for it lately?

  • K013434VP-2000/1000Colin Corp. · 2002

The one decision as Colin Corp. →

Other applicant names beginning “Colin”

FDA records each applicant name separately; these may or may not be the same firm.

Colin Medical Instruments Corp. 15