Cleared Traditional

LNOP BLUE OXIMETRY SENSOR (K051439) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051439 · Masimo Corporation · Anesthesiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jul 2005

Decision

43d

Days

Class 2

Risk

K051439 is an FDA 510(k) clearance for the LNOP BLUE OXIMETRY SENSOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on July 15, 2005 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Masimo Corporation devices

Submission Details

510(k) Number	K051439 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 02, 2005
Decision Date	July 15, 2005
Days to Decision	43 days
Submission Type	Traditional
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

97d faster than avg

Panel avg: 140d · This submission: 43d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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 K051439.

MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS

K053477 · Masimo Corporation · Mar 2006

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

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

LNOPV AD-L AND PD-L OXIMETRY SENSORS

K050068 · Masimo Corporation · Feb 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 K051439

Masimo Corporation

Irvine, CA · US

JAMES J CRONIN

Regulatory profile

85 submissions 83 cleared

98% clearance rate · Active in Anesthesiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

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

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active