510(k) · Cleared
ClearedModification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors, Blood Analysis Portal System Plug-I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boblingen GmbH · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 3, 2001 as substantially equivalent to K002758 (Agilent Technologies Deutschland GmbH, 2001) and 7 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Dec 3, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K941811 (1994). 19 ancestors in all, the oldest K882609 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 1 generation backK992674 HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027AHewlett-Packard GmbH · 1999
- This deviceK013624 Modification to Agilent Component Monitoring System (CMS), V24/V26…Philips Medizin Systeme Boblingen GmbH · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −4 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −3 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −2 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −1 | K992674 | HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027A | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K013624 | Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient… | Philips Medizin Systeme Boblingen GmbH | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002758 | Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive…Summary page 3…ntially equivalent to the previously cleared devices listed below: Manufacturer Device Model 510(k) Agilent Technologies Agilent Component Monitoring System m: :'772//: K002758 MI177A Agilent Component Monitoring System MII75A, K001722 MI1176A, MI177A, MI1205A Agilent Component Monitoring System MI175A,… | 2001 |
| * | K001722 | Agilent Component Monitoring System; Agilent Invasive Blood Pressure ModuleSummary page 3…below: Manufacturer Device Model 510(k) Agilent Technologies Agilent Component Monitoring System m: :'772//: K002758 MI177A Agilent Component Monitoring System MII75A, K001722 MI1176A, MI177A, MI1205A Agilent Component Monitoring System MI175A, K001333 MILI76A, MII77A, M3000A M3046A HP Viridia Compone… | 2000 |
| * | K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…Summary page 3…t Monitoring System m: :'772//: K002758 MI177A Agilent Component Monitoring System MII75A, K001722 MI1176A, MI177A, MI1205A Agilent Component Monitoring System MI175A, K001333 MILI76A, MII77A, M3000A M3046A HP Viridia Component Monitoring System MII175A, K992674 MILI176A, MI1177A Hewlett-Packard M1032A… | 2000 |
| * | K992674 | HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027ASummary page 3…A, K001722 MI1176A, MI177A, MI1205A Agilent Component Monitoring System MI175A, K001333 MILI76A, MII77A, M3000A M3046A HP Viridia Component Monitoring System MII175A, K992674 MILI176A, MI1177A Hewlett-Packard M1032A VueLink Plug-in Module MI1032A K923682 Diametrics Medical, Inc. IRMA Blood Analysis Sys… | 1999 |
| * | K923682 | Model M1032A Vuelink Interface Plug-in ModuleSummary page 3…K001333 MILI76A, MII77A, M3000A M3046A HP Viridia Component Monitoring System MII175A, K992674 MILI176A, MI1177A Hewlett-Packard M1032A VueLink Plug-in Module MI1032A K923682 Diametrics Medical, Inc. IRMA Blood Analysis System Series 2000 K981270 Hewlett-Packard HP Component Monitoring System r\l\/':ll… | 1992 |
| * | K981270 | Irma Blood Analysis SystemSummary page 3…System MII175A, K992674 MILI176A, MI1177A Hewlett-Packard M1032A VueLink Plug-in Module MI1032A K923682 Diametrics Medical, Inc. IRMA Blood Analysis System Series 2000 K981270 Hewlett-Packard HP Component Monitoring System r\l\/':ll :;zj\\ K882609 MI177A i-STAT 200 K940918 Agilent Technologies Agilent… | 1998 |
| * | K882609 | Models M1175A & M1176A Component Monitoring SystemSummary page 3…nk Plug-in Module MI1032A K923682 Diametrics Medical, Inc. IRMA Blood Analysis System Series 2000 K981270 Hewlett-Packard HP Component Monitoring System r\l\/':ll :;zj\\ K882609 MI177A i-STAT 200 K940918 Agilent Technologies Agilent Technologies Agilent Technologies i-STAT i-STAT 200 Portable Clinical… | 1989 |
| * | K940918 | I-Stat 200 Portable Clinical AnalyzerSummary page 3…K923682 Diametrics Medical, Inc. IRMA Blood Analysis System Series 2000 K981270 Hewlett-Packard HP Component Monitoring System r\l\/':ll :;zj\\ K882609 MI177A i-STAT 200 K940918 Agilent Technologies Agilent Technologies Agilent Technologies i-STAT i-STAT 200 Portable Clinical Analyzer 11.9 Modificatio… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 19 ancestors has a recall of any class.
- 1 other device also cites its predicate K002758.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Component Monitoring System and V24/V26 family of patient monitors is intended for the monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by healthcare professionals whenever there is a need for monitoring the physiologic parameters of adult, neonatal, and pediatric patients.
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/K013624 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013624: Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors, Blood Analysis Portal System Plug-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013624
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026