Cleared Traditional

K083622 - LNCS OXIMETRY SENSORS

K083622 is an FDA 510(k) clearance for LNCS OXIMETRY SENSORS, 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 115-day FDA review.

K083622 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
115d
Days
Class 2
Risk

K083622 is an FDA 510(k) clearance for the 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 April 2, 2009 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K083622

510(k) Number K083622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date April 02, 2009
Days to Decision 115 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
25d faster than avg
Panel avg: 140d · This submission: 115d
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 K083622.
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
K091057 · Masimo Corporation · Jul 2009
VITAL SIGNS MONITOR
K083821 · Edan Instruments, Inc. · May 2009
MD2000A VITAL SIGN MONITOR, MODEL MD2000A
K083466 · Beijing Choice Electronic Technololgy Co., Ltd. · Apr 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
K083892 · Cas Medical Systems, Inc. · Mar 2009
N-600X WITH SPD, OXIMAX N-600X
K083325 · Covidien · Mar 2009
M-50 SERIES SPO2 SENSOR
K082487 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2009