510(k) Report

FDA applicant

FMD Co., Ltd.

Shibuya-Ku, JP5 decisions2003–20260 recalls

FDA records 5 decisions for FMD Co., Ltd. (Shibuya-Ku, JP) from 2003 to 2026: 5 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and LNS (Lithotriptor, Extracorporeal Shock-Wave…). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fmd, LLC”.

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 FMD Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 12026 (partial year): 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like FMD Co., Ltd.’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?

  • DQXWire, Guide, Catheter3decisions
  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 118 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 145 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K030346Twinheads TH-101 Extracorporeal Shock Wave LithotripterFmd, LLC · 20033cite it
  • K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire…FMD Co., Ltd. · 2026
  • K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)FMD Co., Ltd. · 2024
  • K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd. · 2022
  • K042561Twinheads TH-103 Extracorporeal Shock Wave LithotripterFmd, LLC · 2004
  • K030346Twinheads TH-101 Extracorporeal Shock Wave LithotripterFmd, LLC · 2003

All 3 as FMD Co., Ltd. →All 2 as Fmd, LLC →