Cleared Traditional

K223721 - Masimo Stork (FDA 510(k) Clearance)

K223721 · Masimo Corporation · Anesthesiology device

Dec 2023

Decision

368d

Days

Class 2

Risk

K223721 is an FDA 510(k) clearance for the Masimo Stork. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on December 15, 2023, 368 days after receiving the submission on December 12, 2022.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K223721 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 12, 2022
Decision Date	December 15, 2023
Days to Decision	368 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF