Cleared Special

K050068 - LNOPV AD-L AND PD-L OXIMETRY SENSORS

K050068 is an FDA 510(k) clearance for LNOPV AD-L AND PD-L 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 28-day FDA review.

K050068 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
28d
Days
Class 2
Risk

K050068 is an FDA 510(k) clearance for the LNOPV AD-L AND PD-L 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 February 9, 2005 after a review of 28 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.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K050068

510(k) Number K050068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2005
Decision Date February 09, 2005
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K050068.
MODEL 2500A PALMSAT PULSE OXIMETER
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AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
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K043359 · Nonin Medical, Inc. · Jan 2005
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K043162 · Card Guard Scientific Survival , Ltd. · Dec 2004