510(k) · Cleared

Cleared

Masimo Radical Y Pulse CO-Oximeter

K110028510(k) SpecialCleared Mar 17, 201171-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 Mar 17, 2011 as substantially equivalent to K100428 (Masimo Corporation, 2010) after a 71-day review. Its family tree reaches back 13 generations to 1997. 1 of the 139 devices in its family, counting itself, has a Class I recall. 89 later devices descend from it.

Decided: Mar 17, 2011
Review: 71 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 13 generations to K962603 (1997). 49 ancestors in all, the oldest K853990 (1985). 89 later devices descend from it, 8 citing it directly. 1 of the 139 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
9 generations between
3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
2 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
1 generation backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
This deviceK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
Descendant · cites it directly · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
Descendant · 2 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
Descendant · 3 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
Descendant · 3 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
Descendant · 4 generations on · 23 of its ownK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019

Show all 13 generations

Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
7 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
6 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
5 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
4 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
2 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
1 generation backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
This deviceK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011

Showing 5 of 89 descendants. See all descendants

Descendants cleared per year

2012high 14 (2024) · low 0 (2013)2026

Class I recalls in this family

K970209 Capnocheck Plus8 generations back · 1997

Most influential descendants

Showing 5 of 89 · See all

K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · cites it directly58descendants
K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 2 generations on51descendants
K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 3 generations on24descendants
K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 3 generations on24descendants
K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019 · 4 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−13	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−12	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−11	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−10	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
−9	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…	Nellcor Puritan Bennett, Inc.	2002	1
−8	K021090	Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter	Nellcor Puritan Bennett, Inc.	2002	—
−7	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…	Cas Medical Systems, Inc.	2004	1
−6	K050844	750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…	Cas Medical Systems, Inc.	2005	—
−5	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3
−4	K072295	Capnostream 20 with A2 Adaptive Averaging Software	Oridion Capnography, Inc.	2007	—
−3	K082268	CAPNOSTREAM20 with Integrated Pulmonary Index	Oridion Capnography, Inc.	2009	9
−2	K091241	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter	Masimo Corporation	2009	—
−1	K100428	Masimo Rainbow Set Radical 7R Pulse CO-Oximeter	Masimo Corporation	2010	—
0 (this device)	K110028	Masimo Radical Y Pulse CO-Oximeter	Masimo Corporation	2011	—
+1	K140188	Masimo Root Monitoring System	Masimo Corporation	2014	—
+2	K142394	Masimo Root Monitoring System and Accesories	Masimo Corporation	2014	—
+3	K151644	Masimo Root Vital Signs Monitoring System and Accessories	Masimo Corporation	2016	—
+3	K150314	Masimo MightySat Rx Fingertip Pulse Oximeter	Masimo Corporation	2015	—
+4	K181956	Masimo MightySat Rx Fingertip Pulse Oximeter	Masimo Corporation	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1990	2	0
1991	2	0
1992	1	0
1993	1	0
1995	4	0
1996	2	0
1997	2	1
1998	4	0
1999	3	0
2000	2	0
2002	2	0
2003	2	0
2004	3	0
2005	2	0
2006	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	5	0
2015	1	0
2016	4	0
2017	4	0
2018	4	0
2019	8	0
2020	8	0
2021	3	0
2022	12	0
2023	8	0
2024	14	0
2025	9	0
2026	8	0

FIG. 1 — Lineage of K110028, 1997–2026Source: 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.

1 device in this family has 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
*	K100428	Masimo Rainbow Set Radical 7R Pulse CO-Oximeter Summary page 1 …ZQ, DPZ, JKS Substantially Equivalent Device Masimo Rainbow SEr*Radical 7R Pulse CO-Oximeters and Accessories, 51 0(k) Number - K1 00428 Description of the Device The Radical 7 Pulse CO-Oximeter and accessories (Radical?7) include the Masimo Rainbow SET technology.…	Masimo Corporation	2010	—

Also cleared against K100428: 7 other devices →

What descends from it? (89)

See all 89

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

Number	Device	Applicant	Decided	Descendants
K140188	Masimo Root Monitoring System	Masimo Corporation	2014	58
K113798	Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set	Draeger Medical Systems, Inc.	2012	23
K133810	VC150 Vital Signs Monitor	Innokas Yhtyma	2014	3
K133988	Tempus Pro Extended Features	Remote Diagnostic Technologies, Ltd.	2014	3
K183687	LifeWindow LW8 Lite	Digicare Biomedical Technology, Inc.	2019	1
K161909	IQvitals Zone	Midmark Corporation	2016	1
K152043	Diagnostic Station DS20	Schiller AG	2016	1
K142915	ZOLL X Series	ZOLL Medical Corporation	2014	0

Has anything in its family been recalled? (1 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.

K970209Capnocheck PlusBci Intl., Inc. · 1997 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 10 months on median.
11 of the 49 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K140188 (Masimo Corporation, 2014) has gone furthest, with 58 descendants of its own.
7 other devices also cite its predicate K100428.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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 (131 words)

The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate to multi-parameter devices for the display of those devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110028 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110028: Masimo Radical Y Pulse CO-Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110028

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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