Cleared Special

K002477 - MASIMO SET RADICAL PULSE OXIMETER WITH ...

K002477 is an FDA 510(k) clearance for MASIMO SET RADICAL PULSE OXIMETER WITH ..., manufactured by Masimo Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 28-day FDA review.

K002477 · Masimo Corp. · Anesthesiology device
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Sep 2000
Decision
28d
Days
Class 2
Risk

K002477 is an FDA 510(k) clearance for the MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AN.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on September 8, 2000 after a review of 28 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.

View all Masimo Corp. devices

FDA 510(k) Submission Details - K002477

510(k) Number K002477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2000
Decision Date September 08, 2000
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K002477.
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER
K002939 · Masimo Corp. · Oct 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002751 · Masimo Corp. · Oct 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002682 · Masimo Corp. · Sep 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
K002574 · Masimo Corp. · Sep 2000
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
K001930 · Nonin Medical, Inc. · Jul 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · Datex-Ohmeda, Inc. · Jun 2000