Data / Medical devices / Mexico / Baja Fur S.A. de C.V.

Baja Fur S.A. de C.V.: FDA-registered device maker in Tijuana Baja California, Mexico, 7 510(k) clearances

Name: Baja Fur S.A. de C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baja Fur S.A. de C.V. is registered with the FDA (registration 3017552925) in Tijuana Baja California, Mexico. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 26, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3017552925
Address: C. Vecinal #20601 Modulos J y K Col. Presa Rodriguez, Tijuana Baja California, Mexico, C.P. 22124
Owner or operator: Outset Medical, Inc. (10047467)
Roles: Manufacturer
First device listed: January 8, 2020
Registered through: 2027
Brand names listed: Tablo Hemodialysis System, Tablo® Cartridge, Tablo® Hemodialysis System, Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer

Devices it lists

Device	Product code	Class	Role	Source
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	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
January 26, 2026	K253412	Tablo Hemodialysis System (PN-0008000, PN-0006000U)	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
May 3, 2024	K232776	Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
December 5, 2023	K233335	Tablo® Hemodialysis System	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
June 21, 2023	K223248	Tablo® Hemodialysis System	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
July 29, 2022	K211370	Tablo Hemodialysis System	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
November 26, 2021	K210782	Tablo Cartridge	FJK	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
December 12, 2019	K190793	Tablo Hemodialysis System, Tablo Cartridge	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 26, 2026. 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.