# Kitazato Biopharma Co., Ltd.

- Location (FDA's records): Fuji, JP
- FDA decisions: 6 (2012–2016): 6 510(k) clearances
- Names in FDA's records: Kitazato Biopharma Co., Ltd. (5); Kitazato Biopharma Co;Ltd (1)
- Product codes: MQL (3), MQK (3)
- 510(k) review time since 2016: median 121 days, against 170 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 3 (0 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
- Irvine Scientific Sales Co., Inc.: 2 (https://510kreport.com/company/irvine-scientific-sales)
- Cryo Bio System: 2 (https://510kreport.com/company/cryo-bio-system)
- Biotech, Inc.: 1 (https://510kreport.com/company/biotech)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)

## Firms that cite its devices most
- Reprolife, Inc.: 1 (https://510kreport.com/company/reprolife)
- Kitazato Corporation: 1 (https://510kreport.com/company/kitazato)
- Shenzhen Vitavitro Bio-Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-vitavitro-bio-tech)

## Its most-cited devices
- K153027: Cryotop US (2016), cited by 2
- K160864: Cryotop Vitrification Kit and Cryotop Thawing Kit (2016), cited by 1

## Recent decisions
- K160864: Cryotop Vitrification Kit and Cryotop Thawing Kit (Oct 7, 2016)
- K160863: PBS (-), Phosphate Buffered Saline (Jul 28, 2016)
- K160142: Mineral Oil (Apr 21, 2016)
- K153027: Cryotop US (Mar 14, 2016)
- K140072: Cryotop (R) SC (Apr 3, 2014)
- K112695: Cryotop (Dec 12, 2012)

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