Cleared Traditional

K962603 - MASIMO SET MS-1 PULSE OXIMETER & THE LN...

K962603 is an FDA 510(k) clearance for MASIMO SET MS-1 PULSE OXIMETER & THE LN..., 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 219-day FDA review.

K962603 · Masimo Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
219d
Days
Class 2
Risk

K962603 is an FDA 510(k) clearance for the MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Mission Viejo, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 219 days - an extended review 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: 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 Corp. devices

FDA 510(k) Submission Details - K962603

510(k) Number K962603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1996
Decision Date February 06, 1997
Days to Decision 219 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
79d slower than avg
Panel avg: 140d · This submission: 219d
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 K962603.
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
8500A PULSE OXIMETER
K945290 · Nonin Medical, Inc. · Feb 1997
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
K963707 · Nellcor Puritan Bennett, Inc. · Dec 1996
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
SCORE SOFTWARE
K961450 · Nellcor Puritan Bennett, Inc. · Aug 1996