510(k) · Cleared
ClearedMasimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · DQA Oximeter
Cleared on Oct 18, 2006 as substantially equivalent to K013199 (Philips Medical Systems, Inc., 2001) and 5 other predicates after a 72-day review. Its family tree reaches back 13 generations to 1994. 38 later devices descend from it.
- Decided
- Oct 18, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K941811 (1994). 63 ancestors in all, the oldest K853990 (1985). 38 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations between
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- This deviceK062268 Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement…Philips Medical Systems North America Co. · 2006
- Descendant · cites it directly · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- Descendant · 5 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
Show all 13 generations
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 12 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 11 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 10 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 9 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 8 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 7 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 6 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 5 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 4 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- This deviceK062268 Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement…Philips Medical Systems North America Co. · 2006
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
2010high 6 (2024) · low 0 (2012)2026
Most influential descendants
Showing 5 of 38 · See all- K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly37descendants
- K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
- K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 4 generations on24descendants
- K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −12 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −11 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −10 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −9 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −8 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −7 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −6 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −5 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −4 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −3 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −2 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −1 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| 0 (this device) | K062268 | Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option… | Philips Medical Systems North America Co. | 2006 | — |
| +1 | K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +2 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| +3 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +4 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| +5 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BSummary page 1…§870.2700, II DQA Oximeter 3. Thenew device is substantially equivalent to previously cleared Philips devices M3001A marketed pursuant to K013199, K020531, K030973 and K040259 as well as the Masimo SET SpO2 plug-in module and and MS-13 Board pursuant to K040259, K05326… | 2001 |
| * | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Summary page 1…§870.2700, II DQA Oximeter 3. Thenew device is substantially equivalent to previously cleared Philips devices M3001A marketed pursuant to K013199, K020531, K030973 and K040259 as well as the Masimo SET SpO2 plug-in module and and MS-13 Board pursuant to K040259, K053269 and K05… | 2002 |
| * | K030973 | Picosat II SPO2 Pulse Oximetry ModuleSummary page 1…§870.2700, II DQA Oximeter 3. Thenew device is substantially equivalent to previously cleared Philips devices M3001A marketed pursuant to K013199, K020531, K030973 and K040259 as well as the Masimo SET SpO2 plug-in module and and MS-13 Board pursuant to K040259, K053269 and K051439. 4. Th… | 2003 |
| * | K040259 | Masimo Set Intellivue Pulse Oximeter ModuleSummary page 1…II DQA Oximeter 3. Thenew device is substantially equivalent to previously cleared Philips devices M3001A marketed pursuant to K013199, K020531, K030973 and K040259 as well as the Masimo SET SpO2 plug-in module and and MS-13 Board pursuant to K040259, K053269 and K051439. 4. The modificati… | 2004 |
| * | K053269 | Masimo Set Rad-8 Pulse OximeterSummary page 1…ps devices M3001A marketed pursuant to K013199, K020531, K030973 and K040259 as well as the Masimo SET SpO2 plug-in module and and MS-13 Board pursuant to K040259, K053269 and K051439. 4. The modification creates the Masimo SET SP02 pulse oximetry module for use in Philips host patient monitors.… | 2005 |
| * | K051439 | Lnop Blue Oximetry SensorSummary page 1…3001A marketed pursuant to K013199, K020531, K030973 and K040259 as well as the Masimo SET SpO2 plug-in module and and MS-13 Board pursuant to K040259, K053269 and K051439. 4. The modification creates the Masimo SET SP02 pulse oximetry module for use in Philips host patient monitors. 5. The new… | 2005 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue… | 2010 | 37 |
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 12 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 4 of the 63 ancestors have a recall of any class.
- Of its descendants, K101600 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) has gone furthest, with 37 descendants of its own.
- 6 other devices also cite its predicate K013199.
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
2007high 35 (2009) · low 9 (2017)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
2007high 317 (2023) · low 97 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
2007high 32 (2018) · low 0 (2012)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
2007high 2,082 (2015) · low 164 (2011)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?
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062268: Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062268
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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