510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113596Substantially Equivalent

Masimo Set Reusable Oximetry Sensors

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

K113596 is the FDA 510(k) clearance record for MASIMO SET REUSABLE OXIMETRY SENSORS, a class II device, cleared for Masimo Corporation on under FDA product code DQA (Oximeter). FDA records list 115 510(k) clearances for Masimo Corporation, from to . As of , FDA records show no recalls naming K113596.

Clearance record

Decision date
Received
(81 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Masimo Corporation 40 Parker, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQA

Trailing 12 months
11 clearances under product code DQA in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260