Cleared Special

LNOPV AD-L AND PD-L OXIMETRY SENSORS (K050068) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050068 · Masimo Corporation · Anesthesiology device

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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

Submission Details

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.

Device Classification

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 239

Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K050068.

LNOP BLUE OXIMETRY SENSOR

K051439 · Masimo Corporation · Jul 2005

MODIFICATION TO LNCS OXIMETRY SENSORS

K051212 · Masimo Corporation · Jul 2005

AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS

K050252 · Masimo Corporation · May 2005

MASIMO SET RAD 57 PULSE CO-OXIMETER

K042536 · Masimo Corporation · Jan 2005

LNCS OXIMETRY SENSORS

K042346 · Masimo Corporation · Sep 2004

THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT

K041674 · Philips Medical Systems · Jul 2004

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K050068

Masimo Corporation

Irvine, CA · US

JAMES CRONIN

Regulatory profile

85 submissions 83 cleared

98% clearance rate · Active in Anesthesiology

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Sourced from FDA 510(k) public files . Updated monthly.

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