510(k) · Cleared
Recalled · 2010Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Jun 23, 2010 as substantially equivalent to K091057 (Masimo Corporation, 2009) after a 127-day review. Its family tree reaches back 9 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 23, 2010
- Review
- 127 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K000126 (2000). 11 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 5 generations between
- 3 generations backK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- 2 generations backK082052 Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot…Masimo Corporation · 2008
- 1 generation backK091057 Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2009
- This deviceK100403 Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories…Masimo Corporation · 2010
- Descendant · cites it directly · 0 of its ownK111403 Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2011
Show all 9 generations
- Root · 9 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 8 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 7 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 6 generations backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
- 5 generations backK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
- 4 generations backK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
- 3 generations backK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- 2 generations backK082052 Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot…Masimo Corporation · 2008
- 1 generation backK091057 Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2009
- This deviceK100403 Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories…Masimo Corporation · 2010
Most influential descendants
Showing 1 of 1 · See all- K111403Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −8 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −7 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −6 | K042536 | Masimo Set Rad 57 Pulse CO-Oximeter | Masimo Corporation | 2005 | 1 |
| −5 | K053477 | Masimo Set Rad 57 CM and M Pulse CO-Oximeters | Masimo Corporation | 2006 | — |
| −4 | K061204 | Masimo Set Radical 7 Pulse CO-Oximeter | Masimo Corporation | 2006 | — |
| −3 | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… | Masimo Corporation | 2008 | 1 |
| −2 | K082052 | Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot Check | Masimo Corporation | 2008 | — |
| −1 | K091057 | Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories | Masimo Corporation | 2009 | — |
| 0 (this device) | K100403 | Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7 | Masimo Corporation | 2010 | — |
| +1 | 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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K091057 | Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesSummary page 1…A Predicate Device: Masimo Rainbow SEr1 Pronto Pulse CO-Oximeter and Accessories, 510O(k) Number - K091 057 Device Description The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-?) include the noninvasive technol… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111403 | Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and Accessories | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2010 | Not classified | Z-1387-2011 | Process design | Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 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, K111403 (Masimo Corporation, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K091057.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SP02), pulse rate, and total hemoglobin concentration (SpHlb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, 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/K100403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100403: Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100403
Report an extraction error
Are you the manufacturer?
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