Data / Medical devices / Mexico / Industrial Vallera de Mexicali, S.A. de C.V. (Terra)

Industrial Vallera de Mexicali, S.A. de C.V. (Terra): FDA-registered device maker in Mexicali Baja California, Mexico, 12 510(k) clearances

Name: Industrial Vallera de Mexicali, S.A. de C.V. (Terra) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Industrial Vallera de Mexicali, S.A. de C.V. (Terra) is registered with the FDA (registration 3016674095) in Mexicali Baja California, Mexico. It lists 23 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 12, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3016674095
Address: Carretera Mexicali-Algodones # 4798 Int. 4-1 Col. Diez Division Dos, Mexicali Baja California, Mexico, 21395
Owner or operator: MASIMO CORPORATION (9031881)
Roles: Manufacturer
First device listed: December 30, 1999
Registered through: 2027
Brand names listed: Centroid, LNCS Disposable Sensors, LNCS Patient Cables, LNCS-II rainbow DCI 8 Lambda, LiDCO, M-LNCS Disposable Sensors, M-LNCS Patient Cables, Masimo SET Rad 57 cm Pulse CO-Oximeter and more

Devices it lists

Device	Product code	Class	Role	Source
Alarm, Blood-Pressure	DSJ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Manufacturer	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Manufacturer	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Manufacturer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Manufacturer	accessdata.fda.gov
Monitor, Bed Patient	KMI	1	Manufacturer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Manufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Manufacturer	accessdata.fda.gov
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	JKS	1	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	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 12, 2026	K253417	Masimo Root Monitoring System	MWI	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
December 15, 2023	K223721	Masimo Stork	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
June 1, 2023	K223498	Radius VSM and Accessories	MHX	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
February 25, 2022	K203113	Masimo SedLine Sedation Monitor and Accessories	OLW	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
April 22, 2020	K191882	Masimo Centroid System	MWI	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
February 27, 2020	K193242	Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories	MWI	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
December 27, 2019	K191059	Masimo Rad-97 and Accessories	MWI	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
March 22, 2019	K182887	Masimo Rad-67 Pulse CO-Oximeter and Accessories	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
October 23, 2018	K180046	Masimo Rad-97 and Accessories	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
October 21, 2010	K101896	MASIMO LNCS/M-LNCS OXIMETRY SENSORS	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
May 12, 2008	K080238	MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
March 16, 2006	K053477	MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov

Compare with other makers

Updated August 12, 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.