# Kitazato Corporation

- Location (FDA's records): Fuji-Shi, JP
- FDA decisions: 13 (2017–2026): 13 510(k) clearances
- Product codes: MQL (8), MQF (3), MQE (1), MQK (1)
- 510(k) review time since 2016: median 231 days, against 228 for FDA's reviews in the same codes and years (5 of 12 faster)
- Predicates its devices cite: 13 (2 its own); citations of its devices by later devices: 12 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- William A. Cook Australia Pty., Ltd.: 2 (https://510kreport.com/company/william-a-cook-australia)
- Kitazato Medical Co., Ltd.: 2 (https://510kreport.com/company/kitazato-medical)
- Irvine Scientific Sales Co., Inc.: 2 (https://510kreport.com/company/irvine-scientific-sales)
- Medicult A/S: 1 (https://510kreport.com/company/medicult-a-s)
- Portex, Inc.: 1 (https://510kreport.com/company/portex)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Kitazato Biopharma Co., Ltd.: 1 (https://510kreport.com/company/kitazato-biopharma)
- Irvine Scientific: 1 (https://510kreport.com/company/irvine-scientific)

## Firms that cite its devices most
- Guangzhou Hehong Biotech Co., Ltd.: 2 (https://510kreport.com/company/guangzhou-hehong-biotech)
- Hamilton Thorne, Inc.: 1 (https://510kreport.com/company/hamilton-thorne)
- Vitrolife Sweden AB: 1 (https://510kreport.com/company/vitrolife-sweden)
- Ecmpc, LLC: 1 (https://510kreport.com/company/ecmpc)
- Shandong Wego Ruisheng Medical Device Co., Ltd.: 1 (https://510kreport.com/company/shandong-wego-ruisheng-medical-device)
- Vitromed GmbH: 1 (https://510kreport.com/company/vitromed)
- Shenzhen Vitavitro Biotech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-vitavitro-biotech)
- Donnevie Medical Technology (Shanghai) Co., Ltd.: 1 (https://510kreport.com/company/donnevie-medical-technology-shanghai)

## Its most-cited devices
- K171748: Vitrification Kit and Thawing Kit (2017), cited by 6
- K190199: SepaSperm Washing Solution, SepaSperm Solution (2019), cited by 2
- K162878: Kitazato ET Catheters (2017), cited by 2
- K181469: Cryotop®US-flash and Cryotop®US-scoop (2018), cited by 1
- K251305: Ultra-Fast Vitri; Ultra-Fast Warm (2025), cited by 1

## Recent decisions
- K260248: Ultra-Fast Warm (Apr 28, 2026)
- K251305: Ultra-Fast Vitri; Ultra-Fast Warm (Aug 26, 2025)
- K200249: Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) (Oct 23, 2020)
- K193522: iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA (Aug 25, 2020)
- K192845: Sperm Freeze, Sperm Fridge (Aug 17, 2020)
- K192540: Kitazato ET Catheters (May 1, 2020)
- K190199: SepaSperm Washing Solution, SepaSperm Solution (Sep 26, 2019)
- K181469: Cryotop®US-flash and Cryotop®US-scoop (Nov 9, 2018)

Source page: https://510kreport.com/company/kitazato