Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016674095

FEI Number

3016674095

Entity Name

Industrial Vallera de Mexicali, S.A. de C.V. (Terra)

City/State/Country

Mexicali Baja California, MX

Establishment Address

Carretera Mexicali-Algodones # 4798 Int. 4-1, Col. Diez Division Dos, Mexicali Baja California 21395, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MASIMO CORPORATION (Owner Number: 9031881)

Owner / Operator Contact Address

52 Discovery, --, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182887

PMA Number

N/A

All Registered Proprietary Names

Stork Hub Stork Vitals Stork Sensor Stork Vitals+ Root Centroid SedLine Sensors SedLine Module RD SedLine Sensors RD SET Multisite Reusable sensors RD Speciality sensors RD SET Reusable sensors RD SET Disposable sensors RD SET Neo Radius VSM and Accessories Radius VSM RAS-45 Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors Masimo SET Rad 57 cm Pulse CO-Oximeter Masimo SET Rad 57 m Pulse CO-Oximeter Masimo SET Red reusable sensors rainbow DCI-mini Rad-67

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-01-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-01-23
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2020-08-03
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2020-08-03
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-08-03
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-03-22
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-03-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-03-22
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-03-22
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-03-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-08-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-05-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-05-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2021-05-14
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-05-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-05-14
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2021-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-05-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-06-05
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2023-06-05
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-06-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-06-05
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-06-05
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-06-05
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-06-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-06-05
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2023-06-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-06-05
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2023-06-05
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-06-05
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-06-05
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	1999-12-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-08-07

Official Correspondent

Mathew Jimenez

US Agent Details

Mathew Jimenez Business: Masimo Corporation Email: MJimenez@masimo.com Phone: (949) 2977558

Related Public Records

Same Entity

MASIMO CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013250653	MASIMO CORPORATION	Irvine, CA, US
3027256461	Masimo Medical Technologies (Malaysia) SDN BHD	Pasir Gudang Johor, MY
3009831876	MASIMO CORPORATION	Irvine, CA, US
3011353843	MASIMO CORPORATION	Irvine, CA, US
3004415095	Industrial Vallera de Mexicali, S. A. de C. V.	Mexicali Mexico, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016674095. Last updated year: 2026. Please use registration number 3016674095 when referencing this establishment in official correspondence.