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MASIMO CORPORATION

USA · Irvine

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

41listed device types

Class I 5Class II 36Class III 0

plus 117 registration records and 115 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 1Class II 6

15 including historic records

SASaudi ArabiaSFDA

6registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

55 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

35device registrations

CLASS B 10CLASS C 25

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

59active ARTG entries

Class I 16IIa 5IIb 38

HKHong KongMDACS

37valid listings

Class III 37

ILIsraelAMAR

20registrations

RURussiaRoszdravnadzor

6active registrations

Class 2b 6

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States117 registration records, 115 510(k), 0 PMA, 1 excluded

Brazil7 confirmed, 1 excluded

Saudi Arabia6 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MASIMO CORPORATION · Masimo Corporation

FDA 510(k) clearances by year

22007

42008

72009

62010

52011

42012

12013

22014

12015

52016

32017

32018

52019

52020

32021

32022

82023

32024

32025

32026

FDA listed device types

showing 8 of 41

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Index-Generating Electroencephalograph Software 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Oximeter, Ear 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253417	Masimo Root Monitoring System	2026-08-12
US	K260880	SedLine Sedation Monitor	2026-07-10
US	K254209	Radius VSM and Accessories	2026-06-04
BR	81944289003	Rad-67® Pulse CO-Oximeter®	Class II
BR	81944289005	RD SedLine para EEG	Class II
BR	81944289002	Oxímetro de pulso para a ponta do dedo MightySat Rx	Class II
SA	ME0000014733SFDAA00016	RD Sedline EEG Sensor Pediatric	—
SA	ME0000001391SFDAA00002	RD Sedline EEG Sensor Pediatric	—