510(k) · Cleared
ClearedMasimo Set Rad-8 Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Dec 21, 2005 as substantially equivalent to K031330 (Masimo Corp., 2003) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 2000. 83 later devices descend from it.
- Decided
- Dec 21, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000126 (2000). 83 later devices descend from it, 5 citing it directly.
- 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 deviceK053269 Masimo Set Rad-8 Pulse OximeterMasimo Corporation · 2005
- Descendant · cites it directly · 38 of its ownK092838 Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8Masimo Corporation · 2009
- Descendant · cites it directly · 38 of its ownK062268 Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement…Philips Medical Systems North America Co. · 2006
- Descendant · 2 generations on · 37 of its ownK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
- Descendant · 2 generations on · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- Descendant · 3 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K092838Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8Masimo Corporation · 2009 · cites it directly38descendants
- K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co. · 2006 · cites it directly38descendants
- K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012 · 2 generations on37descendants
- K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on37descendants
- K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 3 generations on36descendants
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) | K053269 | Masimo Set Rad-8 Pulse Oximeter | Masimo Corporation | 2005 | — |
| +1 | K092838 | Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8 | Masimo Corporation | 2009 | — |
| +1 | K062268 | Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option… | Philips Medical Systems North America Co. | 2006 | — |
| +2 | K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors | Masimo Corporation | 2012 | — |
| +2 | K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +3 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of… | 2003 |
| * | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Summary page 1…) Masioo SET” Radical Palse Oximeter with SatShare™ and the LNOP" series ol Sensors and Cables S1O(K) Number - KO31330 Masimo SET" Rad-3 Pulse Oximeter S10(k) Number - K033296 The Masimo SET" Rad-8 Pulse Oximeter has the following features and benefits: Clinically proven Masimo SET technology performan… | 2004 |
What descends from it? (83)
See all 835 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092838 | Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8 | 2009 | 38 |
| K062268 | Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03 | 2006 | 38 |
| K091564 | NBM-200MP Pulse Oximetry Device | 2010 | 2 |
| K180903 | 3880 MRI Patient Monitoring System | 2019 | 0 |
| K131876 | M Series Patient Monitor | 2014 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K092838 (Masimo Corporation, 2009) has gone furthest, with 38 descendants of its own.
- 13 other devices also cite its predicate K031330.
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® Rad-8 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad-8 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K053269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053269: Masimo Set Rad-8 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053269
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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