Cleared Traditional

K973887 - MASIMO SET MS-1P PULSE OXIMETER AND THE...

K973887 is an FDA 510(k) clearance for MASIMO SET MS-1P PULSE OXIMETER AND THE..., manufactured by Masimo Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K973887 · Masimo Corp. · Anesthesiology device
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Jan 1998
Decision
86d
Days
Class 2
Risk

K973887 is an FDA 510(k) clearance for the MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on January 8, 1998 after a review of 86 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

FDA 510(k) Submission Details - K973887

510(k) Number K973887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date January 08, 1998
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K973887.
MODEL 2000 PULSE OXIMETER
K982255 · Ivy Biomedical Systems, Inc. · Oct 1998
OSCILLOMATE NIBP / SP02 EMS MONITOR
K980879 · Cas Medical Systems, Inc. · Jul 1998
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · Nihon Kohden America, Inc. · Jun 1998
NPB-295 PULSE OXIMETER
K973147 · Nellcor Puritan Bennett, Inc. · Nov 1997
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · Respironics, Inc. · Oct 1997
NPB-290 PULSE OXIMETER (NPB-290)
K972837 · Nellcor Puritan Bennett, Inc. · Oct 1997