510(k) · Cleared

Cleared

Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables

K040214510(k) SpecialCleared Feb 25, 200426-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 25, 2004 as substantially equivalent to K031330 (Masimo Corp., 2003) after a 26-day review. Its family tree reaches back 2 generations to 2000. 2 of the 257 devices in its family, counting itself, have a Class I recall. 254 later devices descend from it.

Decided: Feb 25, 2004
Review: 26 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000126 (2000). 254 later devices descend from it, 5 citing it directly. 2 of the 257 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
1 generation backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
This deviceK040214 Modification to: Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2004
Descendant · cites it directly · 225 of its ownK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
Descendant · 2 generations on · 219 of its ownK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
Descendant · 3 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
Descendant · 3 generations on · 115 of its ownK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
Descendant · 4 generations on · 89 of its ownK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011

Showing 5 of 254 descendants. See all descendants

Descendants cleared per year

2006high 23 (2019) · low 1 (2007)2026

Class I recalls in this family

K123690 CAPNOSTREAM20P with Hifi C02 Monitoring5 generations on · 2014
K160552 EV1000 Clinical Platform with ClearSight Finger…6 generations on · 2016

Most influential descendants

Showing 5 of 254 · See all

K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006 · cites it directly225descendants
K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation · 2008 · 2 generations on219descendants
K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 3 generations on155descendants
K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010 · 3 generations on115descendants
K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011 · 4 generations on89descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000126	Masimo Set Radical Pulse Oximeter with Satshare, Masimo…	Masimo Corp.	2000	—
−1	K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…	Masimo Corp.	2003	—
0 (this device)	K040214	Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop…	Masimo Corp.	2004	—
+1	K061204	Masimo Set Radical 7 Pulse CO-Oximeter	Masimo Corporation	2006	—
+2	K080238	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87…	Masimo Corporation	2008	1
+3	K091241	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter	Masimo Corporation	2009	—
+3	K100428	Masimo Rainbow Set Radical 7R Pulse CO-Oximeter	Masimo Corporation	2010	—
+4	K110028	Masimo Radical Y Pulse CO-Oximeter	Masimo Corporation	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	1	0
2008	4	0
2009	6	0
2010	6	0
2011	7	0
2012	6	0
2013	5	0
2014	15	1
2015	8	0
2016	10	1
2017	10	0
2018	17	0
2019	23	0
2020	15	0
2021	14	0
2022	22	0
2023	23	0
2024	21	0
2025	22	0
2026	17	0

FIG. 1 — Lineage of K040214, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

2 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of… Summary page 1 …tShareTM and LNOP series of Sensors and Cables 5 10(k) Number - K031330 Description of Masimo SET® Radical Pulse Oximeter with SatShareTM The Masimo SET® Radical Pulse Oximeter with Sa…	Masimo Corp.	2003	—

Also cleared against K031330: 13 other devices →

What descends from it? (254)

See all 254

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

Number	Device	Applicant	Decided	Descendants
K061204	Masimo Set Radical 7 Pulse CO-Oximeter	Masimo Corporation	2006	225
K120657	Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors	Masimo Corporation	2012	37
K083705	Bci WW1020 Pulse Oximeter, Model WW1020	Smiths Medical Pm, Inc.	2009	25
K083557	Bci WW1030 Pulse Oximeter	Smiths Medical Pm, Inc.	2009	0
K083787	Bci WW1000 Pulse Oximeter, Model WW1000	Smiths Medical Pm, Inc.	2009	0

Has anything in its family been recalled? (2 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.

K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K061204 (Masimo Corporation, 2006) has gone furthest, with 225 descendants of its own.
13 other devices also cite its predicate K031330.

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	—

What is it indicated for?

Read the full statement (267 words)

The Masimo SET® Radical Pulse Oximeter with SatShare and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShareTM and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShareTM and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShareTM of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for display on those devices.

The Masimo LNOP® Series of Sensors are indicated for the following:

A single use oximetry sensor intended for adults and pediatrics greater than 30 kg

A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg

A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg

A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg

A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg

A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg

The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShareTM.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040214: Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040214

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026