510(k) · Cleared
ClearedMasimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corp. · DQA Oximeter
Cleared on Apr 14, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 of the 561 devices in its family, counting itself, have a Class I recall. 560 later devices descend from it.
- Decided
- Apr 14, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
560 later devices descend from it, 6 citing it directly. 8 of the 561 devices in this family, counting this one, have a Class I recall.
- This deviceK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- Descendant · cites it directly · 519 of its ownK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- Descendant · 2 generations on · 312 of its ownK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- Descendant · 2 generations on · 279 of its ownK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- Descendant · 2 generations on · 254 of its ownK040214 Modification to: Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2004
- Descendant · 3 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 560 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 560 · See all- K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Masimo Corp. · 2003 · cites it directly519descendants
- K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004 · 2 generations on312descendants
- K033296Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Masimo Corp. · 2004 · 2 generations on279descendants
- K040214Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Masimo Corp. · 2004 · 2 generations on254descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on249descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| +2 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| +2 | K040214 | Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2004 | — |
| +3 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 12 | 0 |
| 2005 | 13 | 0 |
| 2006 | 18 | 0 |
| 2007 | 9 | 1 |
| 2008 | 19 | 0 |
| 2009 | 26 | 1 |
| 2010 | 23 | 0 |
| 2011 | 23 | 0 |
| 2012 | 24 | 1 |
| 2013 | 24 | 1 |
| 2014 | 30 | 1 |
| 2015 | 21 | 0 |
| 2016 | 27 | 2 |
| 2017 | 23 | 1 |
| 2018 | 29 | 0 |
| 2019 | 34 | 0 |
| 2020 | 23 | 0 |
| 2021 | 20 | 0 |
| 2022 | 36 | 0 |
| 2023 | 29 | 0 |
| 2024 | 31 | 0 |
| 2025 | 35 | 0 |
| 2026 | 24 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
8 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (560)
See all 5606 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of… | 2003 | 519 |
| K013792 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of… | 2001 | 227 |
| K012992 | Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables | 2001 | 45 |
| K032551 | Masimo Lnop-TF-I Resuable Transflectance Sensor | 2004 | 1 |
| K022037 | Xltek Sleep System | 2002 | 0 |
| K011851 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | 2001 | 0 |
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
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.
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- Of its descendants, K031330 (Masimo Corp., 2003) has gone furthest, with 519 descendants of its own.
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 | — |
https://510kreport.com/device/K000126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000126: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000126
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026