510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200011Unknown

Masimo SafetyNet

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

DEN200011 is the FDA 510(k) clearance record for Masimo SafetyNet, a class II device, cleared for Masimo Corporation on under FDA product code QVT (Monitor For Opioid Induced Impairment Of Oxygenation). FDA's definition for product code QVT reads: "A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose". FDA records list 115 510(k) clearances for Masimo Corporation, from to . As of , FDA records show no recalls naming DEN200011.

Clearance record

Decision date
Received
(1,136 days to decision)
Product code
QVT Monitor For Opioid Induced Impairment Of Oxygenation
Regulation
21 CFR 868.2250
Device class
Class II
Review panel
Anesthesiology
Applicant
Masimo Corporation 52 Discovery, Irvine CA
Third party review
No

Clearances, product code QVT

Trailing 12 months

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

FDA records show no clearances under product code QVT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVT, 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