510(k) · Cleared
ClearedMasimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corp. · DQA Oximeter
Cleared on Jul 11, 2001 as substantially equivalent to K000126 (Masimo Corp., 2000) after a 28-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jul 11, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000126 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- This deviceK011851 Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Masimo Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| 0 (this device) | K011851 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and… | Masimo Corp. | 2001 | — |
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 |
|---|---|---|---|
| * | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric…Summary page 1…(870.2700) : Cable, Transducer and Electrode (74DSA) (870.2900) Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and Cables 510(k) Number - K000126 Description of Masimo SET® Radical Pulse Oximeter with SatShare™ The Masimo SET® Radical Pulse Oximeter with SatShare™ and acce… | 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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K000126.
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® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpQy) and pulse rate (measured by an SpO, sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly…
Read the full statement (344 words)
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpQy) and pulse rate (measured by an SpO, sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are 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. In addition the Masimo SET® Radjcal Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpQ;) and pulse rate (measured by an SpO; sensor) to multi-parameter devices for display on those devices.
The Masimo LNOP® Series of Sensors are indicated for the following:
A single use oximetry sensor intended for adults and pediatrics greater than 30 kg
A single use oximetry sensor intended for pediatrics and smal) adults greater than 10 kg and less than 50 kg
A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg
A single use oximetry sensor intended for neonates with poor skin integrity less than I kg
A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShare™.
The following are additional SatShare cables indicated for connection to the following multi-parameter monitors:
Ohmeda - RGM Respiratory Monitor and
Datex-Ohmeda - M-EST and M-ESTP Modlues
Draeger - Vitalert 1000, 3200, Evita 4, Bvita 2 dura, Julian Anesthetic Workstation, and Narcomed 4 Monitors
Airshields - Multiparameter Monitor with Ohmeda SpQ;
Datascope - Passport Monitor with Datascope SpO; and Accutor Monitors with Nellcor SpO; and Datascope SpO;
GE/Marquette - Tram 100A and Trams 500A modules with Ohmeda SpO,
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/K011851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011851: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011851
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026