510(k) · Cleared
ClearedRainbow Adhesive CO-Oximetry Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Dec 29, 2006 as substantially equivalent to K061204 (Masimo Corporation, 2006) after a 74-day review. Its family tree reaches back 6 generations to 2000. 44 later devices descend from it.
- Decided
- Dec 29, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000126 (2000). 8 ancestors in all, the oldest K853990 (1985). 44 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 5 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 4 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 3 generations backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
- 2 generations backK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
- 1 generation backK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
- This deviceK063140 Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation · 2006
- Descendant · cites it directly · 43 of its ownK071024 Modification to: Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation · 2007
- Descendant · 2 generations on · 41 of its ownK081659 Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20…Masimo Corporation · 2008
- Descendant · 3 generations on · 40 of its ownK090165 Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25…Masimo Corporation · 2009
- Descendant · 4 generations on · 39 of its ownK100617 Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010
- Descendant · 5 generations on · 38 of its ownK111621 Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS…Masimo Corporation · 2011
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K071024Modification to: Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation · 2007 · cites it directly43descendants
- K081659Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-LMasimo Corporation · 2008 · 2 generations on41descendants
- K090165Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20Masimo Corporation · 2009 · 3 generations on40descendants
- K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010 · 4 generations on39descendants
- K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation · 2011 · 5 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −5 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −4 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −3 | K042536 | Masimo Set Rad 57 Pulse CO-Oximeter | Masimo Corporation | 2005 | 1 |
| −2 | K053477 | Masimo Set Rad 57 CM and M Pulse CO-Oximeters | Masimo Corporation | 2006 | — |
| −1 | K061204 | Masimo Set Radical 7 Pulse CO-Oximeter | Masimo Corporation | 2006 | — |
| 0 (this device) | K063140 | Rainbow Adhesive CO-Oximetry Sensors | Masimo Corporation | 2006 | — |
| +1 | K071024 | Modification to: Rainbow Adhesive CO-Oximetry Sensors | Masimo Corporation | 2007 | — |
| +2 | K081659 | Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-L | Masimo Corporation | 2008 | — |
| +3 | K090165 | Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and… | Masimo Corporation | 2009 | — |
| +4 | K100617 | Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D | Masimo Corporation | 2010 | — |
| +5 | K111621 | Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry… | Masimo Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 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 |
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
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 | Decided |
|---|---|---|---|
| * | K061204 | Masimo Set Radical 7 Pulse CO-OximeterSummary page 1….2700) Substantially Equivalent Devices: Masimo SET* Radical 7 Pulse CO-Oximeter with SatShareTM 510(k) Number - K061204 Device Description The Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masirno Rainbow SET and Ma… | 2006 |
| * | — | Rainbow DCI-DC Reusable CO-Oximetry Sensor Named without a submission number |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071024 | Modification to: Rainbow Adhesive CO-Oximetry Sensors | 2007 | 43 |
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 6 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K071024 (Masimo Corporation, 2007) has gone furthest, with 43 descendants of its own.
- 3 other devices also cite its predicate K061204.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 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 Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate (measured by an SP02 sensor), carboxyhemoglobin (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and…
Read the full statement (145 words)
The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate (measured by an SP02 sensor),
carboxyhemoglobin (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an
SpCO/SpMet sensor). The Masimo SET® 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 SET® Radical 7
Pulse CO-Oximeter and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the
Masimo SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen of arterial hemoglobin (SpO 2) and
pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063140 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063140: Rainbow Adhesive CO-Oximetry Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063140
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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