510(k) · Cleared
Recalled · 2006Masimo Set Rad 57 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 Jan 19, 2005 as substantially equivalent to K033296 (Masimo Corp., 2004) and 1 other predicate after a 121-day review. Its family tree reaches back 3 generations to 2000. 2 of the 249 devices in its family, counting itself, have a Class I recall. 244 later devices descend from it. It has been recalled once.
- Decided
- Jan 19, 2005
- Review
- 121 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000126 (2000). 4 ancestors in all, the oldest K853990 (1985). 244 later devices descend from it, 2 citing it directly. 2 of the 249 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 2 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 1 generation backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- This deviceK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005
- Descendant · cites it directly · 226 of its ownK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
- Descendant · 2 generations on · 225 of its ownK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
- Descendant · 2 generations on · 219 of its ownK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- Descendant · 3 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- Descendant · 3 generations on · 115 of its ownK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
Showing 5 of 244 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 244 · See all- K053477Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006 · cites it directly226descendants
- K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006 · 2 generations on225descendants
- K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation · 2008 · 2 generations on219descendants
- K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 3 generations on155descendants
- K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010 · 3 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −2 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −1 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| 0 (this device) | K042536 | Masimo Set Rad 57 Pulse CO-Oximeter | Masimo Corporation | 2005 | — |
| +1 | K053477 | Masimo Set Rad 57 CM and M Pulse CO-Oximeters | Masimo Corporation | 2006 | — |
| +2 | 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 |
| +3 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| +3 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 16 | 1 |
| 2015 | 8 | 0 |
| 2016 | 9 | 1 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 21 | 0 |
| 2020 | 13 | 0 |
| 2021 | 15 | 0 |
| 2022 | 23 | 0 |
| 2023 | 24 | 0 |
| 2024 | 20 | 0 |
| 2025 | 18 | 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? (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 |
|---|---|---|---|
| * | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Summary page 1…(862.3220) Substantially Equivalent Devices Masimo SET Rad 5 Pulse Oximeter and accessories 5 10(k) Number- K033296 Radiometer America, Inc OSM3 Hemoximeter… | 2004 |
| * | K853990 | OSM3 HemoximeterSummary page 1…Number- K033296 Radiometer America, Inc OSM3 Hemoximeter 510(k) Number - K(853990 l)escription of Masinto Rainbow SET® Rad 57 Pulse CO-Oximeter t'he Rad-57 Flaudheld Pulse CO-Oximeter with Rainbow tech… | 1985 |
What descends from it? (244)
See all 2442 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2006 | Not classified | Z-0661-06 | Other | Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading… |
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 · 5 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 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K053477 (Masimo Corporation, 2006) has gone furthest, with 226 descendants of its own.
- 10 other devices also cite its predicate K033296.
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 Rainbow SET Rad 57 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 carboxyhernoglobin saturation (measured by an SpCO sensor). The Masimo SET Rad 57 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/K042536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042536: Masimo Set Rad 57 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/K042536
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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