510(k) · Cleared
ClearedMasimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Jul 9, 2009 as substantially equivalent to K082052 (Masimo Corporation, 2008) after an 87-day review. Its family tree reaches back 8 generations to 2000. 5 later devices descend from it.
- Decided
- Jul 9, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000126 (2000). 10 ancestors in all, the oldest K853990 (1985). 5 later devices descend from it, 3 citing it directly.
- 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 backK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- 1 generation backK082052 Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot…Masimo Corporation · 2008
- This deviceK091057 Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2009
- Descendant · cites it directly · 1 of its ownK124041 NBM-200MPOrsense, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK100403 Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories…Masimo Corporation · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK182887 Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK142209 Pulse oximeter NBM-200Orsense, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK111403 Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2011
Most influential descendants
Showing 5 of 5 · See all- K124041NBM-200MPOrsense, Ltd. · 2013 · cites it directly1descendant
- K100403Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7Masimo Corporation · 2010 · cites it directly1descendant
- K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2019 · cites it directly0descendants
- K142209Pulse oximeter NBM-200Orsense, Ltd. · 2015 · 2 generations on0descendants
- K111403Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2011 · 2 generations on0descendants
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 | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… | Masimo Corporation | 2008 | 1 |
| −1 | K082052 | Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot Check | Masimo Corporation | 2008 | — |
| 0 (this device) | K091057 | Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories | Masimo Corporation | 2009 | — |
| +1 | K124041 | NBM-200MP | Orsense, Ltd. | 2013 | — |
| +1 | K100403 | Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7 | Masimo Corporation | 2010 | 1 |
| +1 | K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2019 | — |
| +2 | K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015 | — |
| +2 | K111403 | Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and Accessories | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K082052 | Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot CheckSummary page 1…ntially Equivalent Devices: Masimno Rainbow SET RadCheck Pulse CO-Oximeters and Accessories, 510(k) Number K082052 Device Description The Masimro Rainbow SET®D Pronto Pulse CO-Oximeter and Accessories in this filing are the same as… | 2008 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K124041 (Orsense, Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K082052.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091057: Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091057
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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