FDA applicant

Kitazato Biopharma Co., Ltd.

Fuji, JP6 decisions2012–20160 recalls

FDA records 6 decisions for Kitazato Biopharma Co., Ltd. (Fuji, JP) from 2012 to 2016: 6 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQK (Labware, Assisted Reproduction). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kitazato Biopharma Co;Ltd”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

4in 2016

2012high 4 (2016) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

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

Planning a device like Kitazato Biopharma 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

Other applicant names beginning “Kitazato”

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

Kitazato Corporation 13 Kitazato Medical Co., Ltd. 3

Kitazato Biopharma Co., Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Kitazato”