Cleared Special

MODIFICATION TO LNCS OXIMETRY SENSORS (K051212) - FDA 510(k) Clearance

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

K051212 · Masimo Corporation · Anesthesiology device

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Jul 2005

Decision

62d

Days

Class 2

Risk

K051212 is an FDA 510(k) clearance for the MODIFICATION TO 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 July 12, 2005 after a review of 62 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	K051212 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 11, 2005
Decision Date	July 12, 2005
Days to Decision	62 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

78d faster than avg

Panel avg: 140d · This submission: 62d

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 K051212.

MASIMO SET RAD-8 PULSE OXIMETER

K053269 · Masimo Corporation · Dec 2005

DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT

K052755 · Ge Healthcare · Oct 2005

LNOP BLUE OXIMETRY SENSOR

K051439 · Masimo Corporation · Jul 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

MASIMO SET RAD 57 PULSE CO-OXIMETER

K042536 · Masimo Corporation · Jan 2005

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 K051212

Masimo Corporation

Irvine, CA · US

JAMES J CRONIN

Regulatory profile

85 submissions 83 cleared

98% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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

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