510(k) · Cleared

Cleared

Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-L

K081659510(k) TraditionalCleared Sep 9, 200889-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 Sep 9, 2008 as substantially equivalent to K080238 (Masimo Corporation, 2008) and 1 other predicate after an 89-day review. Its family tree reaches back 8 generations to 2000. 41 later devices descend from it.

Decided: Sep 9, 2008
Review: 89 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 2

Its longest line of descent runs back 8 generations to K000126 (2000). 11 ancestors in all, the oldest K853990 (1985). 41 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
7 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
6 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
5 generations backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
4 generations backK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
3 generations backK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
2 generations backK063140 Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation · 2006
1 generation backK071024 Modification to: Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation · 2007
This deviceK081659 Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20…Masimo Corporation · 2008
Descendant · cites it directly · 40 of its ownK090165 Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25…Masimo Corporation · 2009
Descendant · 2 generations on · 39 of its ownK100617 Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010
Descendant · 3 generations on · 38 of its ownK111621 Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS…Masimo Corporation · 2011
Descendant · 4 generations on · 37 of its ownK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
Descendant · 5 generations on · 34 of its ownK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2009high 6 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 41 · See all

K090165Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20Masimo Corporation · 2009 · cites it directly40descendants
K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010 · 2 generations on39descendants
K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation · 2011 · 3 generations on38descendants
K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012 · 4 generations on37descendants
K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH · 2015 · 5 generations on34descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K000126	Masimo Set Radical Pulse Oximeter with Satshare, Masimo…	Masimo Corp.	2000	—
−7	K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…	Masimo Corp.	2003	—
−6	K033296	Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse…	Masimo Corp.	2004	1
−5	K042536	Masimo Set Rad 57 Pulse CO-Oximeter	Masimo Corporation	2005	1
−4	K053477	Masimo Set Rad 57 CM and M Pulse CO-Oximeters	Masimo Corporation	2006	—
−3	K061204	Masimo Set Radical 7 Pulse CO-Oximeter	Masimo Corporation	2006	—
−2	K063140	Rainbow Adhesive CO-Oximetry Sensors	Masimo Corporation	2006	—
−1	K071024	Modification to: Rainbow Adhesive CO-Oximetry Sensors	Masimo Corporation	2007	—
0 (this device)	K081659	Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-L	Masimo Corporation	2008	—
+1	K090165	Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and…	Masimo Corporation	2009	—
+2	K100617	Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D	Masimo Corporation	2010	—
+3	K111621	Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry…	Masimo Corporation	2011	—
+4	K120657	Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors	Masimo Corporation	2012	—
+5	K150975	Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…	Philips Medizin Systeme Boeblingen GmbH	2015	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
2004	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2014	1	0
2015	2	0
2016	2	0
2017	2	0
2018	4	0
2019	4	0
2020	1	0
2021	1	0
2022	3	0
2023	6	0
2024	1	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K081659, 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.

Planning a device in DQA? 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

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What was it cleared against? (2)

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
*	K080238	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse… Summary page 1 …valent Devices: Masimo Rainbow SET Radical 7/ Rad 87/ Rad 57t Pulse CO-Oximeters and Accessories, 510(k) Number K080238 Masimo Rainbow Adhesive CO-Oximetry Sensors,…	Masimo Corporation	2008	1
*	K071024	Modification to: Rainbow Adhesive CO-Oximetry Sensors Summary page 1 …k) Number K080238 Masimo Rainbow Adhesive CO-Oximetry Sensors, 510(k) Number K071024 Device Description The Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masimo Rainbow SET and Ma…	Masimo Corporation	2007	—

Also cleared against K080238: 10 other devices →

What descends from it? (41)

See all 41

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090165	Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20	Masimo Corporation	2009	40

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 11 months on median.
3 of the 11 ancestors have a recall of any class.
Of its descendants, K090165 (Masimo Corporation, 2009) has gone furthest, with 40 descendants of its own.
10 other devices also cite its predicate K080238.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

The Rainbow Adhesive Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Adhesive Sensors 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081659: Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081659

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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