Cleared Special

K094046 - LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS

K094046 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 134-day FDA review.

K094046 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
134d
Days
Class 2
Risk

K094046 is an FDA 510(k) clearance for the LNCS OXIMETRY SENSORS, REPROCESSED 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 May 14, 2010 after a review of 134 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. 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. Standard predicate reliance. 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 - K094046

510(k) Number K094046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2009
Decision Date May 14, 2010
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
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 K094046.
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
K093853 · Nonin Medical, Inc. · Jun 2010
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D
K100617 · Masimo Corporation · May 2010
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
K100203 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2010
VITAL SIGNS MONITOR
K093016 · Shenzhen Creative Industry Co., Ltd. · Mar 2010
NBM-200MP PULSE OXIMETRY DEVICE
K091564 · Orsense, Ltd. · Mar 2010
SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
K092950 · Solaris Medical Technology, Inc. · Mar 2010