510(k) · Cleared

Cleared

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

K031330510(k) SpecialCleared May 12, 200314-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 May 12, 2003 as substantially equivalent to K000126 (Masimo Corp., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 8 of the 521 devices in its family, counting itself, have a Class I recall. 519 later devices descend from it.

Decided: May 12, 2003
Review: 14 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000126 (2000). 519 later devices descend from it, 14 citing it directly. 8 of the 521 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
This deviceK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
Descendant · cites it directly · 312 of its ownK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
Descendant · cites it directly · 279 of its ownK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
Descendant · cites it directly · 254 of its ownK040214 Modification to: Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2004
Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
Descendant · 3 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 519 descendants. See all descendants

Descendants cleared per year

2003high 34 (2022) · low 1 (2003)2026

Class I recalls in this family

K070377 Giraffe and Panda Warmer2 generations on · 2007
K123309 Giraffe and Panda Warmers3 generations on · 2013
K090697 Modification to: Giraffe and Panda Warmer3 generations on · 2009
K111473 Uni-Vent (R) Model 731 Series Portable Critical…5 generations on · 2012

Most influential descendants

Showing 5 of 519 · See all

K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004 · cites it directly312descendants
K033296Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Masimo Corp. · 2004 · cites it directly279descendants
K040214Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Masimo Corp. · 2004 · cites it directly254descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants
K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on247descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000126	Masimo Set Radical Pulse Oximeter with Satshare, Masimo…	Masimo Corp.	2000	—
0 (this device)	K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…	Masimo Corp.	2003	—
+1	K040259	Masimo Set Intellivue Pulse Oximeter Module	Masimo Corp.	2004	—
+1	K033296	Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse…	Masimo Corp.	2004	1
+1	K040214	Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop…	Masimo Corp.	2004	—
+2	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—
+3	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	9	0
2005	13	0
2006	16	0
2007	8	1
2008	18	0
2009	25	1
2010	22	0
2011	23	0
2012	21	1
2013	23	1
2014	29	1
2015	21	0
2016	23	2
2017	23	1
2018	26	0
2019	30	0
2020	23	0
2021	19	0
2022	34	0
2023	27	0
2024	30	0
2025	32	0
2026	23	0

FIG. 1 — Lineage of K031330, 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.

8 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
*	K000126	Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric…	Masimo Corp.	2000	—

Also cleared against K000126: 5 other devices →

What descends from it? (519)

See all 519

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

Number	Device	Applicant	Decided	Descendants
K040259	Masimo Set Intellivue Pulse Oximeter Module	Masimo Corp.	2004	312
K033296	Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…	Masimo Corp.	2004	279
K040214	Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…	Masimo Corp.	2004	254
K033715	Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server	Philips Medical Systems, Inc.	2004	186
K033298	SPO2.Com Oximetry Sensors, Multiple Models	Masimo Corp.	2003	95
K041815	LNCS Oximetry Sensors	Masimo Corp.	2004	86
K053269	Masimo Set Rad-8 Pulse Oximeter	Masimo Corporation	2005	83
K073036	Fore-Sight, MC-2000 Series	Cas Medical Systems, Inc.	2008	59
K083892	Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)	Cas Medical Systems, Inc.	2009	58
K033349	AC-1 SP02 Adaptor Cable, Model AC-1	Masimo Corp.	2004	2

Has anything in its family been recalled? (8 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.

K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K153046Hamilton-MR1Hamilton Medical AG · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K040259 (Masimo Corp., 2004) has gone furthest, with 312 descendants of its own.
5 other devices also cite its predicate K000126.

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 (260 words)

The Masimo SET@Radical Pulse Oximeter with SatShareTM and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an Sp02 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 SatShareThland 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 (SpOz) and pulse rate (measured by an Sp02 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/K031330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031330: 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/K031330

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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