Cleared Traditional

MightySat -OTC

K214115 · Masimo Corporation · Anesthesiology
Jan 2024
Decision
762d
Days
Class 2
Risk

About This 510(k) Submission

K214115 is an FDA 510(k) clearance for the MightySat -OTC, a Pulse Oximeter For Over-the-counter Use (Class II — Special Controls, product code OLK), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on January 31, 2024, 762 days after receiving the submission on December 30, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K214115 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2021
Decision Date January 31, 2024
Days to Decision 762 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code OLK — Pulse Oximeter For Over-the-counter Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700
Definition Non-wearable, Fingertip Pulse Oximeter Intended For Over-the-counter Use For Non-continuous Monitoring