FDA applicant

Sakura Seiki Co., Ltd.

Great Neck, NY3 decisions2012–20141 recall

FDA records 3 decisions for Sakura Seiki Co., Ltd. (Great Neck, NY) from 2012 to 2014: 3 510(k) clearances. All are in product code FLE (Sterilizer, Steam). Its devices cite 3 predicates, 2 of them its own earlier devices. 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2014

2012high 1 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2019

2012high 1 (2019) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Sakura Seiki Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sakura Seiki 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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Other applicant names beginning “Sakura”

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

Sakura Finetek U.S.A., Inc. 4

Sakura Seiki Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sakura”