510(k) Report

FDA applicant

Yamaha Motor Co., Ltd.

Iwata City, JP3 decisions2014–20260 recalls

FDA records 3 decisions for Yamaha Motor Co., Ltd. (Iwata City, JP) from 2014 to 2026: 3 510(k) clearances. All are in product code ITI (Wheelchair, Powered). Its devices cite 6 predicates, 2 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, physical medicine panel, where it files most

How often FDA has decided Yamaha Motor Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12021: 12026 (partial year): 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Yamaha Motor Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yamaha Motor Co., Ltd.’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?

  • ITIWheelchair, Powered3decisions

Whose devices does it build on?

Its devices cite 6 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.

  • K140204JWX-2Yamaha Motor Co., Ltd. · 20143cite it
  • K203806JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K252101JWG-1Yamaha Motor Co., Ltd. · 2026
  • K203806JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. · 2021
  • K140204JWX-2Yamaha Motor Co., Ltd. · 2014

All 3 as Yamaha Motor Co., Ltd. →