Cleared Traditional

K033296 - MASIMO SET RAD-5 PULSE OXIMETER

Also marketed or referenced as:
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

K033296 is an FDA 510(k) clearance for MASIMO SET RAD-5 PULSE OXIMETER, manufactured by Masimo Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K033296 · Masimo Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
128d
Days
Class 2
Risk

K033296 is an FDA 510(k) clearance for the MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on February 19, 2004 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corp. devices

FDA 510(k) Submission Details - K033296

510(k) Number K033296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date February 19, 2004
Days to Decision 128 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
12d faster than avg
Panel avg: 140d · This submission: 128d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K033296.
MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K040214 · Masimo Corp. · Feb 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979 · Philips Medical Systems, Inc. · Feb 2004
MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
K032551 · Masimo Corp. · Feb 2004
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
K033715 · Philips Medical Systems, Inc. · Feb 2004
AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
K033349 · Masimo Corp. · Jan 2004
SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
K033298 · Masimo Corp. · Dec 2003