510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K234021Substantially Equivalent

Masimo Stork

Masimo Corporation, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K234021 is the FDA 510(k) clearance record for Masimo Stork, a class II device, cleared for Masimo Corporation on under FDA product code QYU (Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use). FDA's definition for product code QYU reads: "An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when...". FDA records list 115 510(k) clearances for Masimo Corporation, from to . As of , FDA records show no recalls naming K234021.

Clearance record

Decision date
Received
(135 days to decision)
Product code
QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Regulation
21 CFR 870.2705
Device class
Class II
Review panel
Cardiovascular
Applicant
Masimo Corporation 52 Discovery, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYU

Trailing 12 months

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

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