Cleared Special

K051212 - MODIFICATION TO LNCS OXIMETRY SENSORS

K051212 is an FDA 510(k) clearance for MODIFICATION TO LNCS 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 62-day FDA review.

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

FDA 510(k) Submission Details - K051212

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.

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 K051212.
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
K052755 · Ge Healthcare · Oct 2005
OXIMAX NPB-40 HANDHELD PULSE OXIMETER
K051352 · Nellcor Puritan Bennett, Inc. · Aug 2005
LNOP BLUE OXIMETRY SENSOR
K051439 · 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
ONYX II FINGER PULSE OXIMETER, MODEL 9550
K051107 · Nonin Medical, Inc. · Jun 2005