510(k) · Cleared
ClearedModification of Philips Component Compact Monitor, Release a.03, Model M1275B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DSI Detector And Alarm, Arrhythmia
Cleared on May 8, 2002 as substantially equivalent to K013199 (Philips Medical Systems, Inc., 2001) and 5 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1994. 421 later devices descend from it.
- Decided
- May 8, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K941811 (1994). 36 ancestors in all, the oldest K872781 (1987). 421 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 2 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 1 generation backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- This deviceK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- Descendant · cites it directly · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- Descendant · 2 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- Descendant · 2 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- Descendant · 2 generations on · 375 of its ownK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
Showing 5 of 421 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 421 · See all- K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · cites it directly407descendants
- K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 2 generations on406descendants
- K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 2 generations on404descendants
- K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 2 generations on376descendants
- K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Philips Medizin Systeme Boblingen GmbH · 2003 · 2 generations on375descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −5 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −4 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −3 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −2 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −1 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| +1 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| +2 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| +2 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| +2 | 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 | — |
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 | 8 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 16 | 0 |
| 2007 | 7 | 0 |
| 2008 | 14 | 0 |
| 2009 | 19 | 0 |
| 2010 | 20 | 0 |
| 2011 | 20 | 0 |
| 2012 | 19 | 0 |
| 2013 | 17 | 0 |
| 2014 | 15 | 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 | 29 | 0 |
| 2026 | 20 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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 2…c, General clinical Hospital The new device is substantially equivalent to the previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed purs… | 2001 |
| * | K990125 | HP Viridia Component Monitoring System, Model Rev. KSummary page 2…nt to the previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed pursuant to K951127, K982619, & K994188, and the Philips M3 marketed pursu… | 1999 |
| * | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas ModuleSummary page 2…ice marketed pursuant to K013199, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed pursuant to K951127, K982619, & K994188, and the Philips M3 marketed pursuant to K971910. The modification is updated software and the ability to co… | 1995 |
| * | K982619 | HP Anesthesia Gas Monitor (Watertrap), Model A02Summary page 2…ted pursuant to K013199, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed pursuant to K951127, K982619, & K994188, and the Philips M3 marketed pursuant to K971910. The modification is updated software and the ability to connect to… | 1998 |
| * | K994188 | Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5Summary page 2…t to K013199, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed pursuant to K951127, K982619, & K994188, and the Philips M3 marketed pursuant to K971910. The modification is updated software and the ability to connect to the Philips… | 2000 |
| * | K971910 | Multi-Parameter Module (M3000A)/Display Unit (M3046A)Summary page 2…stem marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed pursuant to K951127, K982619, & K994188, and the Philips M3 marketed pursuant to K971910. The modification is updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module. The new device ha… | 1998 |
What descends from it? (421)
See all 4214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | 2002 | 407 |
| K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry… | 2004 | 260 |
| K030973 | Picosat II SPO2 Pulse Oximetry Module | 2003 | 198 |
| K081937 | Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry… | 2008 | 49 |
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 2.1 years on median.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K021778 (Philips Medical Systems, 2002) has gone furthest, with 407 descendants of its own.
- 6 other devices also cite its predicate K013199.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
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.
EASTI 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 / tcpCO02) is restricted to neonatal patients only.
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/K021300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021300: Modification of Philips Component Compact Monitor, Release a.03, 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/K021300
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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