Cleared Traditional

K223721 - Masimo Stork

K223721 is an FDA 510(k) clearance for Masimo Stork, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K223721 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
368d
Days
Class 2
Risk

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

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on December 15, 2023 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K223721

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 140d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K223721.
Vyvo
K231288 · Vyvo Technology Corp.(Vt) · Mar 2024
Pulse Oximeter(Model OHT60,OXH78)
K230277 · Cofoe Medical Technology Co., Ltd. · Jan 2024
Pediarity™
K231531 · Hinlab, Inc. · Dec 2023
Wrist Pulse Oximeter
K230587 · Beijing Choice Electronic Technology Co., Ltd. · Nov 2023
Finger Clip Pulse Oximeter
K231243 · Guangdong Genial Technology Co., Ltd. · Oct 2023
Carescape SpO2 - Masimo
K232389 · Masimo Corporation · Sep 2023