Cleared Traditional

K042536 - MASIMO SET RAD 57 PULSE CO-OXIMETER

K042536 is an FDA 510(k) clearance for MASIMO SET RAD 57 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 121-day FDA review.

K042536 · Masimo Corporation · Anesthesiology device
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Jan 2005
Decision
121d
Days
Class 2
Risk

K042536 is an FDA 510(k) clearance for the MASIMO SET RAD 57 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 January 19, 2005 after a review of 121 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 Corporation devices

FDA 510(k) Submission Details - K042536

510(k) Number K042536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date January 19, 2005
Days to Decision 121 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
19d faster than avg
Panel avg: 140d · This submission: 121d
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 K042536.
ONYX II FINGER PULSE OXIMETER, MODEL 9550
K051107 · Nonin Medical, Inc. · Jun 2005
AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
K050252 · Masimo Corporation · May 2005
LNOPV AD-L AND PD-L OXIMETRY SENSORS
K050068 · Masimo Corporation · Feb 2005
4100 PATIENT OXIMETER MODULE
K043359 · Nonin Medical, Inc. · Jan 2005
PMP4 OXY PRO
K043162 · Card Guard Scientific Survival , Ltd. · Dec 2004
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
K042306 · Philips Medizin Systeme Boeblingen GmbH · Oct 2004