Cleared Traditional

MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS (K990966) - FDA 510(k) Clearance

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

K990966 · Masimo Corp. · Anesthesiology device
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Jun 1999
Decision
76d
Days
Class 2
Risk

K990966 is an FDA 510(k) clearance for the MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE S.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on June 7, 1999 after a review of 76 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 Corp. devices

Submission Details

510(k) Number K990966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1999
Decision Date June 07, 1999
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 140d · This submission: 76d
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 182
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K990966.
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
K022193 · Ge Medical Systems Information Technologies · Aug 2002
INFINITY MICRO2+
K012770 · Siemens Medical Solutions USA, Inc. · Jul 2002
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · Nihon Kohden America, Inc. · Jan 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K991661 · Siemens Medical Solutions USA, Inc. · May 1999
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · Nihon Kohden America, Inc. · Jun 1998
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · Respironics, Inc. · Oct 1997