Cleared Traditional

K212161 - Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories (FDA 510(k) Clearance)

K212161 · Masimo Corporation · Anesthesiology device

Mar 2023

Decision

602d

Days

Class 2

Risk

K212161 is an FDA 510(k) clearance for the Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on March 6, 2023, 602 days after receiving the submission on July 12, 2021.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K212161 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 12, 2021
Decision Date	March 06, 2023
Days to Decision	602 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 870.2300