510(k) Report

FDA applicant

Kitazato Corporation

Fuji-Shi, JP13 decisions2017–20260 recalls

FDA records 13 decisions for Kitazato Corporation (Fuji-Shi, JP) from 2017 to 2026: 13 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQF (Catheter, Assisted Reproduction). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 228 for FDA’s reviews in the same codes and years. Its devices cite 13 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2025

2017: 42018: 22019: 12020: 42025: 12026 (partial year): 1
2017high 4 (2017) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Kitazato Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kitazato Corporation’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?

  • MQLMedia, Reproductive8decisions
  • MQFCatheter, Assisted Reproduction3decisions
  • MQENeedle, Assisted Reproduction1decision
  • MQKLabware, Assisted Reproduction1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 231 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 228 days; 5 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 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.

  • K171748Vitrification Kit and Thawing KitKitazato Corporation · 20176cite it
  • K190199SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation · 20192cite it
  • K162878Kitazato ET CathetersKitazato Corporation · 20172cite it
  • K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation · 20181cites it
  • K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 20251cites it

What has FDA decided for it lately?

  • K260248Ultra-Fast WarmKitazato Corporation · 2026
  • K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025
  • K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium…Kitazato Corporation · 2020
  • K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAKitazato Corporation · 2020
  • K192845Sperm Freeze, Sperm FridgeKitazato Corporation · 2020
  • K192540Kitazato ET CathetersKitazato Corporation · 2020
  • K190199SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation · 2019
  • K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation · 2018

All 13 as Kitazato Corporation →

Other applicant names beginning “Kitazato”

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

Kitazato Biopharma Co., Ltd. 6Kitazato Medical Co., Ltd. 3