510(k) · Cleared
ClearedMasimo Set Rad-5V Pulse Oximeter, Model Rad-5V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corp. · DQA Oximeter
Cleared on Mar 19, 2004 as substantially equivalent to K031330 (Masimo Corp., 2003) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Mar 19, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000126 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 1 generation backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- This deviceK033998 Masimo Set Rad-5V Pulse Oximeter, Model Rad-5VMasimo Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −1 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| 0 (this device) | K033998 | Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V | Masimo Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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…Summary page 1…eter with SatShareTll and LNOP series of Sensors and Cables 5 10O(k) Number - K03 1330O Nonin Model 2500 Pulse Oximeter - -510(k) Number - KO001930 The Masimo SETP Rad-S… | 2003 |
| * | K001930 | Model 8500, Hand Held Pulse Oximeter, Model 8500Summary page 1…5 10O(k) Number - K03 1330O Nonin Model 2500 Pulse Oximeter - -510(k) Number - KO001930 The Masimo SETP Rad-Sv Handlield Pulse Oxinmeter is noninvasive. arterial oxvge strioand pulse rate monitor. The Rad-… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
- 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 SETO Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor). The Masimo SET® Rad 5v Pulse Oximeter is 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/K033998 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033998: Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033998
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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