Cleared Special

K212876 - Carescape SpO2 - Masimo

K212876 is an FDA 510(k) clearance for Carescape SpO2 - Masimo, manufactured by Masimo Corporation. The device is a Class 2 Cardiovascular device with product code DQA cleared through the Special 510(k) pathway after a 29-day FDA review.

K212876 · Masimo Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
29d
Days
Class 2
Risk

K212876 is an FDA 510(k) clearance for the Carescape SpO2 - Masimo. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on October 8, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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 - K212876

510(k) Number K212876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2021
Decision Date October 08, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
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 Cardiovascular 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 K212876.
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
K211632 · Shenzhen Narig Bio-Medical Technology Co., Ltd. · Jan 2022
Pulse Oximeter
K210305 · Dongguan Lingxin Technologies Co., Ltd. · Dec 2021
Belun Ring BLR-100X
K211407 · Belun Technology Company Limited · Oct 2021
Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
K210032 · Leadtek Research, Inc. · Sep 2021
Fingertip Pulse Oximeter
K210274 · Zhuhai Linte Medical Instrument Co., Ltd. · Jul 2021
VS Newborn Heart Rate Monitor
K201887 · Surepulse Medical Limited · Jul 2021
K212876 · Carescape SpO2 - Masimo
Download PDF FDA Summary Masimo Corporation