Cleared Traditional

K033998 - MASIMO SET RAD-5V PULSE OXIMETER

K033998 is an FDA 510(k) clearance for MASIMO SET RAD-5V 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 86-day FDA review.

K033998 · Masimo Corp. · Anesthesiology device
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Mar 2004
Decision
86d
Days
Class 2
Risk

K033998 is an FDA 510(k) clearance for the MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on March 19, 2004 after a review of 86 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 Corp. devices

FDA 510(k) Submission Details - K033998

510(k) Number K033998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date March 19, 2004
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
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 K033998.
MODIFICATION TO AVANT 9600 PULSE OXIMETER
K040589 · Nonin Medical, Inc. · Jun 2004
NVISION DATA MANAGEMENT SOFTWARE
K033307 · Nonin Medical, Inc. · May 2004
MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
K040259 · Masimo Corp. · Apr 2004
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