Cleared Traditional

K051439 - LNOP BLUE OXIMETRY SENSOR

K051439 is an FDA 510(k) clearance for LNOP BLUE OXIMETRY SENSOR, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K051439 · Masimo Corporation · Anesthesiology device
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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

FDA 510(k) Submission Details - K051439

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.

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 K051439.
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MODIFICATION TO LNCS OXIMETRY SENSORS
K051212 · Masimo Corporation · Jul 2005
750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL
K050844 · Cas Medical Systems, Inc. · Jun 2005
MODEL 2500A PALMSAT PULSE OXIMETER
K050056 · Nonin Medical, Inc. · Jun 2005