Cleared Special

K042346 - LNCS OXIMETRY SENSORS

K042346 is an FDA 510(k) clearance for LNCS OXIMETRY SENSORS, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 21-day FDA review.

K042346 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
21d
Days
Class 2
Risk

K042346 is an FDA 510(k) clearance for the LNCS OXIMETRY SENSORS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on September 20, 2004 after a review of 21 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.

FDA 510(k) Submission Details - K042346

510(k) Number K042346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2004
Decision Date September 20, 2004
Days to Decision 21 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
119d faster than avg
Panel avg: 140d · This submission: 21d
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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K042346.
REUSABLE FINGER CLIP SPO2 SENSORS
K042704 · Elekon Industries U.S.A., Inc. · Nov 2004
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
K042306 · Philips Medizin Systeme Boeblingen GmbH · Oct 2004
ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
K042501 · Hitachi Medical Corp. · Oct 2004
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
K041522 · Elekon Industries U.S.A., Inc. · Sep 2004
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
K041964 · Mediaid, Inc. · Sep 2004
PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
K040178 · S.P.O. Medical Equipment, Ltd. · Sep 2004