510(k) · Cleared
Recalled · Class II · 2015Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on May 12, 2008 as substantially equivalent to K061204 (Masimo Corporation, 2006) and 2 other predicates after a 102-day review. Its family tree reaches back 6 generations to 2000. 2 of the 228 devices in its family, counting itself, have a Class I recall. 219 later devices descend from it. It has been recalled once.
- Decided
- May 12, 2008
- Review
- 102 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000126 (2000). 8 ancestors in all, the oldest K853990 (1985). 219 later devices descend from it, 11 citing it directly. 2 of the 228 devices in this family, counting this one, have a Class I recall.
- 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 deviceK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008
- Descendant · cites it directly · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- Descendant · cites it directly · 115 of its ownK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- Descendant · 2 generations on · 89 of its ownK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
- Descendant · cites it directly · 67 of its ownK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- Descendant · 2 generations on · 66 of its ownK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
Showing 5 of 219 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 219 · See all- K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · cites it directly155descendants
- K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010 · cites it directly115descendants
- K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011 · 2 generations on89descendants
- K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · cites it directly67descendants
- K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 2 generations on66descendants
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) | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… | Masimo Corporation | 2008 | — |
| +1 | 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 | — |
| +2 | K110028 | Masimo Radical Y Pulse CO-Oximeter | Masimo Corporation | 2011 | — |
| +1 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| +2 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 15 | 1 |
| 2015 | 7 | 0 |
| 2016 | 8 | 1 |
| 2017 | 9 | 0 |
| 2018 | 12 | 0 |
| 2019 | 21 | 0 |
| 2020 | 11 | 0 |
| 2021 | 14 | 0 |
| 2022 | 22 | 0 |
| 2023 | 23 | 0 |
| 2024 | 20 | 0 |
| 2025 | 16 | 0 |
| 2026 | 15 | 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.
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
What was it cleared against? (3)
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….3220) Substantially Equivalent Devices Masimo Rainbow SETO Radical 7 Pulse CO-Oximeter and Accessories 510(k) Number - K061204 Masimo Rainbow SET ® Rad 57cm/m Pulse CO-Oximeters and Accessories… | 2006 |
| * | K053477 | Masimo Set Rad 57 CM and M Pulse CO-OximetersSummary page 1…204 Masimo Rainbow SET ® Rad 57cm/m Pulse CO-Oximeters and Accessories 510(k) Number - K053477 Radiometer America, Inc. OSM3 Hemoximeter 5 10… | 2006 |
| * | K853990 | OSM3 HemoximeterSummary page 1…510(k) Number - K053477 Radiometer America, Inc. OSM3 Hemoximeter 5 10(k) Number - K853990 Description of the Device The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories (Radical 7), the Masimo Rainbow… | 1985 |
What descends from it? (219)
See all 21911 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | 2009 | 155 |
| K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | 2010 | 115 |
| K110516 | Connex Vital Signs Monitor 6000 Series | 2011 | 67 |
| K101123 | Nexfin Model 2 | 2010 | 54 |
| K081659 | Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-L | 2008 | 41 |
| K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors | 2012 | 37 |
| K101995 | Capnostream 20P with Masimo SPO2 Board | 2011 | 7 |
| K082052 | Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot Check | 2008 | 6 |
| K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | 2013 | 2 |
| K124041 | NBM-200MP | 2013 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2015 | Class II | Z-0338-2016 | Finished device change control | These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters. |
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 · 3 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 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 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 1.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K091241 (Masimo Corporation, 2009) has gone furthest, with 155 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. 2008, this device’s year, is highlighted.
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 Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow…
Read the full statement (341 words)
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow 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 Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate (measured by an SPO2 sensor) to multi-parameter devices for the display of those devices.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SPO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SETO Rad 87 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.
The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter 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) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masino Rainbow SET®Rad-57 t 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080238
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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