Data / Medical devices / United States / Visby Medical, Inc.

Visby Medical, Inc.: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance

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

Visby Medical, Inc. is registered with the FDA (registration 3016608638) in San Jose, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 26, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016608638
Address: 3010 North First Street, San Jose, CA, United States, 95134
Owner or operator: Visby Medical, Inc. (10080245)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: January 21, 2021
Registered through: 2026
Brand names listed: Visby Medical COVID-19 Test, Visby Medical Sexual Health Click Test

Devices it lists

Device	Product code	Class	Role	Source
Dna Probe, Nucleic Acid Amplification, Chlamydia	MKZ	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Dna-Reagents, Neisseria	LSL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	QEP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Complaint file establishment, Manufacturer	accessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test System	OUY	2	Complaint file establishment, Manufacturer, Specification developer	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, 2021	K200748	Visby Medical Sexual Health	QEP	Substantially Equivalent	Visby Medical	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 5, 2020	87049	Class II	Terminated	visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency U	Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.	accessdata.fda.gov

Compare with other makers

Updated August 26, 2021. 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.