510(k) · Cleared
ClearedPhilips Component Compact Monitor, Release a.04, Model #M1275B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DQA Oximeter
Cleared on Jul 17, 2002 as substantially equivalent to K013199 (Philips Medical Systems, Inc., 2001) and 6 other predicates after a 48-day review. Its family tree reaches back 7 generations to 1994. 407 later devices descend from it.
- Decided
- Jul 17, 2002
- Review
- 48 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K941811 (1994). 47 ancestors in all, the oldest K872781 (1987). 407 later devices descend from it, 31 citing it directly.
- Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 3 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 2 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 1 generation backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- This deviceK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- Descendant · cites it directly · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- Descendant · cites it directly · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- Descendant · cites it directly · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- Descendant · cites it directly · 375 of its ownK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- Descendant · 2 generations on · 312 of its ownK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
Showing 5 of 407 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 407 · See all- K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · cites it directly406descendants
- K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · cites it directly404descendants
- K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · cites it directly376descendants
- K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Philips Medizin Systeme Boblingen GmbH · 2003 · cites it directly375descendants
- K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004 · 2 generations on312descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −6 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −5 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −4 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −3 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −2 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −1 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| 0 (this device) | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| +1 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| +1 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| +1 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| +1 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| +2 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 9 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 14 | 0 |
| 2007 | 6 | 0 |
| 2008 | 14 | 0 |
| 2009 | 15 | 0 |
| 2010 | 20 | 0 |
| 2011 | 19 | 0 |
| 2012 | 19 | 0 |
| 2013 | 17 | 0 |
| 2014 | 14 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 17 | 0 |
| 2018 | 25 | 0 |
| 2019 | 17 | 0 |
| 2020 | 14 | 0 |
| 2021 | 18 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 0 |
| 2026 | 19 | 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? (8)
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 |
|---|---|---|---|
| * | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BSummary page 2…troence~halosram 3. The new device is substantially equivalent to the,previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, K020531, and K021300, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1021A S v O z… | 2001 |
| * | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Summary page 2…alosram 3. The new device is substantially equivalent to the,previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, K020531, and K021300, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1021A S v O z Module m… | 2002 |
| * | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275BSummary page 2…. The new device is substantially equivalent to the,previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, K020531, and K021300, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1021A S v O z Module marketed pursu… | 2002 |
| * | K990125 | HP Viridia Component Monitoring System, Model Rev. KSummary page 2…Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, K020531, and K021300, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1021A S v O z Module marketed pursuant to K942843, the Philips M1027A EEG Module marketed pursuant to K99… | 1999 |
| Kept off the family tree | K942843 | FDA’s K942843 is Cervex-Brush (R), Sterile, Spatula, Cervical, Cytology Our reading of the summary gave K942843, FDA’s number for Cervex-Brush (R), Sterile, Spatula, Cervical, Cytology (Rovers Diagnostic Devices). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips M1021A SvOz Module”. Kept off the family tree. Summary page 2…to K013199, K020531, and K021300, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1021A S v O z Module marketed pursuant to K942843, the Philips M1027A EEG Module marketed pursuant to K992674, the Philips M1034A BIS Module marketed pursuant to K003038, an… | 1994 |
| * | K992674 | HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027ASummary page 2…itoring System marketed pursuant to K990125 with the Philips M1021A S v O z Module marketed pursuant to K942843, the Philips M1027A EEG Module marketed pursuant to K992674, the Philips M1034A BIS Module marketed pursuant to K003038, and the Philips M2391A PC Client marketed pursuant to K021422.… | 1999 |
| * | K003038 | Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model…Summary page 2…M1021A S v O z Module marketed pursuant to K942843, the Philips M1027A EEG Module marketed pursuant to K992674, the Philips M1034A BIS Module marketed pursuant to K003038, and the Philips M2391A PC Client marketed pursuant to K021422. 4. The modification is updated software and the ability to s… | 2000 |
| * | K021422 | Philips Information Center Software Revision D.02Summary page 2…s M1027A EEG Module marketed pursuant to K992674, the Philips M1034A BIS Module marketed pursuant to K003038, and the Philips M2391A PC Client marketed pursuant to K021422. 4. The modification is updated software and the ability to support to the Philips M1021A SvOz Module, M1027A EEG Module, an… | 2002 |
What descends from it? (407)
See all 40731 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient… | 2002 | 406 |
| K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185… | 2003 | 404 |
| K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | 2003 | 376 |
| K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. | 2003 | 375 |
| K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | 2004 | 253 |
| K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | 2004 | 252 |
| K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors | 2004 | 251 |
| K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors | 2005 | 250 |
| K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 | 2005 | 249 |
| K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors | 2005 | 247 |
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 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 2 of the 47 ancestors have a recall of any class.
- Of its descendants, K023871 (Philips Medical Systems, 2002) has gone furthest, with 406 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
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 patients. Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. EASI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpC02)…
Read the full statement (124 words)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpC02) is restricted to neonatal patients only.
Bispectral Index (BIS) monitoring is for use in monitoring the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. The Bispectral Index, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents*.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021778 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021778
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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