510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K214115Substantially Equivalent

MightySat -OTC

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

K214115 is the FDA 510(k) clearance record for MightySat -OTC, a class II device, cleared for Masimo Corporation on under FDA product code OLK (Pulse Oximeter For Over-The-Counter Use). FDA's definition for product code OLK reads: "Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring". FDA records list 115 510(k) clearances for Masimo Corporation, from to . As of , FDA records show no recalls naming K214115.

Clearance record

Decision date
Received
(762 days to decision)
Product code
OLK Pulse Oximeter For Over-The-Counter Use
Regulation
21 CFR 870.2700
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 OLK

Trailing 12 months

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

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