Data / Medical devices / Japan / Kitazato Corporation

Kitazato Corporation: FDA-registered device maker in Fuji Shizuoka, Japan, 21 510(k) clearances

Name: Kitazato Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kitazato Corporation is registered with the FDA (registration 3008876063) in Fuji Shizuoka, Japan. It lists 8 device types. The FDA files 21 510(k) clearances under its listings, the newest dated August 26, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Kitazato Corporation

FDA registration number: 3008876063
Address: 100-10 Yanagishima, Fuji Shizuoka, Japan, 416-0932
Owner or operator: Kitazato Corporation (10045321)
Roles: Complaint file establishment, Exporter to the US, Manufacturer
First device listed: November 5, 2013
Registered through: 2026
Brand names listed: Blastocyst Medium [without HSA/rHA, with HSA, with rHA]), Catheter 3Fr or 4Fr and Guide, Catheter 3Fr or 4Fr and Guide with Obturator, Catheter 4.7Fr Supported (EC-PRO Supported), Catheters 4.7Fr(EC-PRO), Cleavage Medium [without HSA/rHA, with HSA, with rHA], Cryotop Vitrification Kit and Cryotop Thawing Kit, CryotopCL and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Assisted Reproduction	MQF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Labware, Assisted Reproduction	MQK	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Labware, Assisted Reproduction, Exempt	PUD	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Media, Reproductive	MQL	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Media, Reproductive, Exempt	QKI	2	Manufacturer	accessdata.fda.gov
Microtools, Assisted Reproduction (Pipettes), Exempt	PUC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Needle, Assisted Reproduction	MQE	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 26, 2025	K251305	Ultra-Fast Vitri; Ultra-Fast Warm	MQL	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
October 23, 2020	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])	MQL	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
August 25, 2020	K193522	iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA	MQL	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
August 17, 2020	K192845	Sperm Freeze, Sperm Fridge	MQL	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
May 1, 2020	K192540	Kitazato ET Catheters	MQF	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
September 26, 2019	K190199	SepaSperm Washing Solution, SepaSperm Solution	MQL	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
November 9, 2018	K181469	Cryotop®US-flash and Cryotop®US-scoop	MQK	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
October 23, 2018	K182002	Cumulus Remover	MQL	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
December 14, 2017	K171748	Vitrification Kit and Thawing Kit	MQL	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
July 13, 2017	K162878	Kitazato ET Catheters	MQF	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
July 11, 2017	K162881	Kitazato OPU Needles	MQE	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
May 11, 2017	K162667	Kitazato IUI Catheter	MQF	Substantially Equivalent	Kitazato Corporation	accessdata.fda.gov
October 7, 2016	K160864	Cryotop Vitrification Kit and Cryotop Thawing Kit	MQL	Substantially Equivalent	Kitazato Biopharma Co., Ltd.	accessdata.fda.gov
July 28, 2016	K160863	PBS(-), Phosphate Buffered Saline	MQL	Substantially Equivalent	Kitazato Biopharma Co., Ltd.	accessdata.fda.gov
April 21, 2016	K160142	MINERAL OIL	MQL	Substantially Equivalent	Kitazato Biopharma Co., Ltd.	accessdata.fda.gov
March 14, 2016	K153027	Cryotop US	MQK	Substantially Equivalent	Kitazato Biopharma Co., Ltd.	accessdata.fda.gov
April 3, 2014	K140072	CRYOTOP(R) SC	MQK	Substantially Equivalent	Kitazato Biopharma Co., Ltd.	accessdata.fda.gov
September 11, 2013	K131491	KITAZATO IUI CATHETER	MQF	Substantially Equivalent	Kitazato Medical Co., Ltd.	accessdata.fda.gov
December 12, 2012	K112695	CRYOTOP	MQK	Substantially Equivalent	Kitazato Biopharma Co;Ltd	accessdata.fda.gov
November 26, 2012	K112462	KITAZATO OPU NEEDLE	MQE	Substantially Equivalent	Kitazato Medical Co., Ltd.	accessdata.fda.gov
November 2, 2012	K112396	IUI CATHETERS	MQF	Substantially Equivalent	Kitazato Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.