510(k) · Cleared

Cleared

Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables

K962603510(k) TraditionalCleared Feb 6, 1997219-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Feb 6, 1997 after a 219-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 of the 1,003 devices in its family, counting itself, have a Class I recall. 1,002 later devices descend from it.

Decided: Feb 6, 1997
Review: 219 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

1,002 later devices descend from it, 2 citing it directly. 47 of the 1,003 devices in this family, counting this one, have a Class I recall.

This deviceK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
Descendant · cites it directly · 1,000 of its ownK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
Descendant · 2 generations on · 816 of its ownK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
Descendant · 3 generations on · 785 of its ownK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
Descendant · 3 generations on · 715 of its ownK993637 N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · Recalled
Descendant · 4 generations on · 548 of its ownK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled

Showing 5 of 1,002 descendants. See all descendants

Descendants cleared per year

1998high 57 (2025) · low 1 (2000)2026

Class I recalls in this family

K070594 Palmtop Ventilator, Models PTV-8, PTV-104 generations on · 2007
K090888 Newport HT70 Family of Ventilators4 generations on · 2009
K093261 MOVES5 generations on · 2010
K070377 Giraffe and Panda Warmer5 generations on · 2007

Most influential descendants

Showing 5 of 1,002 · See all

K973887Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesMasimo Corp. · 1998 · cites it directly1,000descendants
K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998 · 2 generations on816descendants
K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999 · 3 generations on785descendants
K993637N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · 3 generations on715descendants
K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc. · 2002 · 4 generations on548descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
+1	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
+2	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
+3	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
+3	K993637	N-395 Pulse Oximeter, with Extended Device Claims	Nellcor Puritan Bennett, Inc.	1999	1
+4	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…	Nellcor Puritan Bennett, Inc.	2002	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	6	0
2000	1	0
2001	1	0
2002	13	0
2003	14	0
2004	26	0
2005	20	0
2006	37	1
2007	17	2
2008	33	2
2009	45	2
2010	42	1
2011	50	8
2012	52	5
2013	47	5
2014	43	3
2015	52	2
2016	41	2
2017	47	4
2018	45	0
2019	52	3
2020	43	3
2021	33	3
2022	48	0
2023	49	1
2024	45	0
2025	57	0
2026	41	0

FIG. 1 — Lineage of K962603, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

47 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1,002)

See all 1,002

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	1,000
K990199	Smartrecorder, Model 2500	Respironics, Inc.	1999	0

Has anything in its family been recalled? (47 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
K093261MOVESThornhill Research, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K062267Oxylog 3000Drager Medical B.V. · 2006 · 5 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls

Nearest 12 of 47 shown.

Nearest 5 of 47; all are on the web page.

What does this lineage say?

Of its descendants, K973887 (Masimo Corp., 1998) has gone furthest, with 1,000 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

https://510kreport.com/device/K962603 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962603: Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962603

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026