510(k) · Cleared
ClearedMasimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Sep 19, 2012 as substantially equivalent to K033296 (Masimo Corp., 2004) and 9 other predicates after a 198-day review. Its family tree reaches back 17 generations to 1994. 1 of the 157 devices in its family, counting itself, has a Class I recall. 37 later devices descend from it.
- Decided
- Sep 19, 2012
- Review
- 198 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 17 generations to K941811 (1994). 119 ancestors in all, the oldest K853990 (1985). 37 later devices descend from it, 2 citing it directly. 1 of the 157 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 13 generations between
- 3 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 2 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- 1 generation backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- This deviceK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
- Descendant · cites it directly · 34 of its ownK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
- Descendant · 2 generations on · 31 of its ownK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
- Descendant · 3 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
- Descendant · 3 generations on · 6 of its ownK221704 HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP)…Edwards Lifesciences, LLC · 2022
- Descendant · 3 generations on · 6 of its ownK210906 IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850…Philips Medizin Systeme Boeblingen GmbH · 2021 · Recalled
Show all 17 generations
- Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 16 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 15 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 14 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 13 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 12 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 11 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 10 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 9 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 8 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 7 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 6 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 5 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 4 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 3 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 2 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- 1 generation backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- This deviceK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
Most influential descendants
Showing 5 of 37 · See all- K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH · 2015 · cites it directly34descendants
- K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH · 2016 · 2 generations on31descendants
- K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 3 generations on8descendants
- K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC · 2022 · 3 generations on6descendants
- K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH · 2021 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −16 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −15 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −14 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −13 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −12 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −11 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −10 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −9 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −8 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −7 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −6 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −5 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −4 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| −3 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
| −2 | K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | Masimo Corporation | 2010 | — |
| −1 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | — |
| 0 (this device) | K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors | Masimo Corporation | 2012 | — |
| +1 | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | Philips Medizin Systeme Boeblingen GmbH | 2015 | 1 |
| +2 | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement… | Philips Medizin Systeme Boeblingen GmbH | 2016 | 1 |
| +3 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 4 |
| +3 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global… | Edwards Lifesciences, LLC | 2022 | — |
| +3 | K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2021 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 6 | 1 |
| 1998 | 9 | 0 |
| 1999 | 10 | 0 |
| 2000 | 12 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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.
1 device in this family has 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? (11)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Summary page 1…Y-I Oximetry Sensors Masimo ReSposable SpO; Series Oximetry Sensors Pulse Oximeter and Oximeter Sensor 21 CFR 870.2700 / Class It DQA Masimo SET Rad 5 Pulse Oximeter (K033296) Masimo SET Rad 5v Pulse Oximeter (K040214) Masimo SET Rad 8 Pulse Oximeter (K092838) Masimo rainbow SET® Rad 57 Pulse CO-Oxim… | 2004 |
| * | K040214 | Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Summary page 1…Series Oximetry Sensors Pulse Oximeter and Oximeter Sensor 21 CFR 870.2700 / Class It DQA Masimo SET Rad 5 Pulse Oximeter (K033296) Masimo SET Rad 5v Pulse Oximeter (K040214) Masimo SET Rad 8 Pulse Oximeter (K092838) Masimo rainbow SET® Rad 57 Pulse CO-Oximeter (K080238) Masimo rainbow SET® Radical 7… | 2004 |
| * | K092838 | Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8Summary page 1…d Oximeter Sensor 21 CFR 870.2700 / Class It DQA Masimo SET Rad 5 Pulse Oximeter (K033296) Masimo SET Rad 5v Pulse Oximeter (K040214) Masimo SET Rad 8 Pulse Oximeter (K092838) Masimo rainbow SET® Rad 57 Pulse CO-Oximeter (K080238) Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (K 110280 Masimo rainbow… | 2009 |
| * | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Summary page 1…SET Rad 5 Pulse Oximeter (K033296) Masimo SET Rad 5v Pulse Oximeter (K040214) Masimo SET Rad 8 Pulse Oximeter (K092838) Masimo rainbow SET® Rad 57 Pulse CO-Oximeter (K080238) Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (K 110280 Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241) Masimo LNOP Oxi… | 2008 |
| Kept off the family tree | K110280 | FDA’s K110280 is Revlok Fenestrated Screw System Our OCR of the scanned summary read K110280, FDA’s number for Revlok Fenestrated Screw System (Globus Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Masimo rainbow SET Radical 7 Pulse CO-Oximeter”. Kept off the family tree. Summary page 1…se Oximeter (K040214) Masimo SET Rad 8 Pulse Oximeter (K092838) Masimo rainbow SET® Rad 57 Pulse CO-Oximeter (K080238) Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (K 110280 Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241) Masimo LNOP Oximetry Sensors (K111888) Masimo LNCS/M-LNCS Oximetry Sensor… | 2011 |
| * | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterSummary page 1…(K092838) Masimo rainbow SET® Rad 57 Pulse CO-Oximeter (K080238) Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (K 110280 Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241) Masimo LNOP Oximetry Sensors (K111888) Masimo LNCS/M-LNCS Oximetry Sensors (K051212 and K101896) Masimo LNOP/M-LNCS/LNCS Multi… | 2009 |
| * | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsSummary page 1…ulse CO-Oximeter (K080238) Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (K 110280 Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241) Masimo LNOP Oximetry Sensors (K111888) Masimo LNCS/M-LNCS Oximetry Sensors (K051212 and K101896) Masimo LNOP/M-LNCS/LNCS Multisite-L. Oximetry Sensors (K111888) Mas… | 2011 |
| * | K051212 | Modification to LNCS Oximetry SensorsSummary page 1…Radical 7 Pulse CO-Oximeter (K 110280 Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241) Masimo LNOP Oximetry Sensors (K111888) Masimo LNCS/M-LNCS Oximetry Sensors (K051212 and K101896) Masimo LNOP/M-LNCS/LNCS Multisite-L. Oximetry Sensors (K111888) Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors (K012… | 2005 |
| * | K101896 | Masimo LNCS/M-LNCS Oximetry SensorsSummary page 1…lse CO-Oximeter (K 110280 Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241) Masimo LNOP Oximetry Sensors (K111888) Masimo LNCS/M-LNCS Oximetry Sensors (K051212 and K101896) Masimo LNOP/M-LNCS/LNCS Multisite-L. Oximetry Sensors (K111888) Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors (K012992) Masimo… | 2010 |
| * | K012992 | Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and CablesSummary page 1…Masimo LNCS/M-LNCS Oximetry Sensors (K051212 and K101896) Masimo LNOP/M-LNCS/LNCS Multisite-L. Oximetry Sensors (K111888) Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors (K012992) Masimo ReSposable SpO; Series Oximetry Sensors (K111621)… | 2001 |
| * | K111621 | Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsSummary page 1…Masimo LNOP/M-LNCS/LNCS Multisite-L. Oximetry Sensors (K111888) Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors (K012992) Masimo ReSposable SpO; Series Oximetry Sensors (K111621) X… | 2011 |
What descends from it? (37)
See all 372 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 14 of the 119 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150975 (Philips Medizin Systeme Boeblingen GmbH, 2015) has gone furthest, with 34 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. 2012, this device’s year, is highlighted.
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 Rad 5 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 Rad 5 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.…
Read the full statement (814 words)
The Masimo Rad 5 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 Rad 5 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.
The Masimo Rad 5v 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 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.
The Masimo Rad 8 Pulse 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). The Masimo Rainbow Rad 8 Pulse Oximeter 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.
The Masimo 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 total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rad 57 Pulse CO-Oximeter 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.
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical 7 Pulse CO-Oximeter 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. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The Masimo Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RR). The Masimo Rad 87 Pulse CO-Oximeter 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.
The Masimo LNOP Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor) for use with adult, pediatric, infant, 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.
The Masimo LNCS/M-LNCS Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor) for use with adult, pediatric, infant, 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.
The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor) for use with adult, pediatric, infant, 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.
The Masimo LNOP/M-LNCS/LNCS V-I Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor) for use with adult, pediatric, infant, 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.
The Masimo ReSposable SPO2 Series Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor) for use with adult, pediatric, infant, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120657: Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120657
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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