Cleared Traditional

Masimo Stork

K234021 · Masimo Corporation · Cardiovascular
May 2024
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K234021 is an FDA 510(k) clearance for the Masimo Stork, a Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use (Class II — Special Controls, product code QYU), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on May 3, 2024, 135 days after receiving the submission on December 20, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2705.

Submission Details

510(k) Number K234021 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2023
Decision Date May 03, 2024
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QYU — Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2705
Definition 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 Vital Sign(s) Go Outside Preset Threshold(s).