Cleared Traditional

K061204 - MASIMO SET RADICAL 7 PULSE CO-OXIMETER

K061204 is an FDA 510(k) clearance for MASIMO SET RADICAL 7 PULSE CO-OXIMETER, 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 87-day FDA review.

K061204 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
87d
Days
Class 2
Risk

K061204 is an FDA 510(k) clearance for the MASIMO SET RADICAL 7 PULSE CO-OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on July 27, 2006 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K061204

510(k) Number K061204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2006
Decision Date July 27, 2006
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K061204.
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
K062268 · Philips Medical Systems North America Co. · Oct 2006
PULSE OXIMETER, MODEL PM-50
K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2006
NELLCOR OXIMAX N-600X PULSE OXIMETER
K060576 · Nellcor Puritan Bennett, Inc. · Aug 2006
INFINITY MASIMO SET SP02 POD
K061329 · Draeger Medical Systems, Inc. · Jul 2006
LNCS AND SPO2.COM SENSORS
K060143 · Masimo Corporation · Jun 2006
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
K053381 · Welch Allyn, Inc. · Jun 2006