FDA applicant

Sb-Kawasumi Laboratories, Inc.

Kanagawa, JP5 decisions2022–20250 recalls

FDA records 5 decisions for Sb-Kawasumi Laboratories, Inc. (Kanagawa, JP) from 2022 to 2025: 5 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and PTI (Non-Coring (Huber) Needle). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 171 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Sb-Kawasumi Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2022high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Sb-Kawasumi Laboratories, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sb-Kawasumi Laboratories, 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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Sb-Kawasumi Laboratories, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?