Cleared Special

K221953 - Masimo CARESCAPE SpO2 – Masimo with SpHb

K221953 is an FDA 510(k) clearance for Masimo CARESCAPE SpO2 – Masimo with SpHb, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 30-day FDA review.

K221953 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
30d
Days
Class 2
Risk

K221953 is an FDA 510(k) clearance for the Masimo CARESCAPE SpO2 – Masimo with SpHb. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on August 4, 2022 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221953

510(k) Number K221953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2022
Decision Date August 04, 2022
Days to Decision 30 days
Submission Type Special
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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K221953.
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K203208 · Taiwan Aulisa Medical Devices Technologies, Inc. · Jun 2022
WesperO2
K213515 · Wesper, Inc. · Jun 2022
K221953 · Masimo CARESCAPE SpO2 – Masimo with SpHb
Download PDF FDA Summary Masimo Corporation