510(k) · Cleared
Recalled · 2006Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · DQA Oximeter
Cleared on Feb 13, 2004 as substantially equivalent to K030973 (Philips Medical Systems, 2003) and 2 other predicates after a 79-day review. Its family tree reaches back 8 generations to 1994. 186 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 13, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 8 generations to K941811 (1994). 41 ancestors in all, the oldest K872781 (1987). 186 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 4 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 3 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 2 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- 1 generation backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- This deviceK033715 Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement…Philips Medical Systems, Inc. · 2004
- Descendant · cites it directly · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 2 generations on · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · 2 generations on · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · 2 generations on · 143 of its ownK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
- Descendant · 2 generations on · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 186 · See all- K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly176descendants
- K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on175descendants
- K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on151descendants
- K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH · 2008 · 2 generations on143descendants
- K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · 2 generations on127descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −7 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −6 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −5 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −4 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −3 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −2 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| −1 | K030973 | Picosat II SPO2 Pulse Oximetry Module | Philips Medical Systems | 2003 | — |
| 0 (this device) | K033715 | Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server | Philips Medical Systems, Inc. | 2004 | — |
| +1 | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +2 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| +2 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| +2 | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| +2 | K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 15 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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? (4)
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 |
|---|---|---|---|
| * | K030973 | Picosat II SPO2 Pulse Oximetry ModuleSummary page 1…r and Respiratory Therapy (12624) 3. The new device is substantially equivalent to previously cleared Philips devices M3001A and picoSAT module marketed pursuant to K030973 and K021330 as well as the Masimo SET pulse oximeter marketed pursuant to K031330 and K013792. 4. The modification improve… | 2003 |
| Kept off the family tree | K021330 | FDA’s K021330 is Magnetom Trio Quadrature TX/RX Head Coil Our reading of the summary gave K021330, FDA’s number for Magnetom Trio Quadrature TX/RX Head Coil (Usa Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “picoSAT module”. Kept off the family tree. Summary page 1…tory Therapy (12624) 3. The new device is substantially equivalent to previously cleared Philips devices M3001A and picoSAT module marketed pursuant to K030973 and K021330 as well as the Masimo SET pulse oximeter marketed pursuant to K031330 and K013792. 4. The modification improves the perform… | 2002 |
| * | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Summary page 1…to previously cleared Philips devices M3001A and picoSAT module marketed pursuant to K030973 and K021330 as well as the Masimo SET pulse oximeter marketed pursuant to K031330 and K013792. 4. The modification improves the performance of the FAST pulse oximetry algorithm. 5. The new devices have t… | 2003 |
| * | K013792 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Summary page 1…y cleared Philips devices M3001A and picoSAT module marketed pursuant to K030973 and K021330 as well as the Masimo SET pulse oximeter marketed pursuant to K031330 and K013792. 4. The modification improves the performance of the FAST pulse oximetry algorithm. 5. The new devices have the same inte… | 2001 |
What descends from it? (186)
See all 1865 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062392 | Philips MP5 Intellivue Patient Monitor | 2006 | 176 |
| K090360 | Philips M3001A Multi Measurement Server | 2009 | 84 |
| K081937 | Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry… | 2008 | 49 |
| K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue… | 2010 | 37 |
| K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | 2005 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2006 | Not classified | Z-0183-2007 | Other | Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM |
| Sep 21, 2006 | Not classified | Z-0184-2007 | Other | Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM |
| Jul 24, 2006 | Not classified | Z-1487-06 | Other | Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 41 ancestors has a recall of any class.
- Of its descendants, K062392 (Philips Medizin Systeme Boeblingen GmbH, 2006) has gone furthest, with 176 descendants of its own.
- 9 other devices also cite its predicate K030973.
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?
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 hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033715 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033715: Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033715
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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