510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200076Unknown

ORi

Masimo Corporation, Irvine CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200076 is the FDA 510(k) clearance record for ORi, a class II device, cleared for Masimo Corporation on under FDA product code QWE (Hyperoxia Monitoring Device Adjunct To Pulse Oximetry). FDA's definition for product code QWE reads: "A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring". FDA records list 115 510(k) clearances for Masimo Corporation, from to . As of , FDA records show no recalls naming DEN200076.

Clearance record

Decision date
Received
(1,025 days to decision)
Product code
QWE Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Regulation
21 CFR 870.2720
Device class
Class II
Review panel
Anesthesiology
Applicant
Masimo Corporation 52 Discovery, Irvine CA
Third party review
No

Clearances, product code QWE

Trailing 12 months

FDA records hold no clearances under product code QWE in the trailing twelve months.

FDA records show no clearances under product code QWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260