510(k) · Cleared
Recalled · 2011HP Carevue 9000 Clinical Information System, Model M2331A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Aug 31, 1999 as substantially equivalent to K922210 (Hewlett-Packard Co., 1993) and 4 other predicates after a 25-day review. Its family tree reaches back 4 generations to 1994. 78 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 31, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- 8
- Predicates
- 5
Its longest line of descent runs back 4 generations to K941811 (1994). 14 ancestors in all, the oldest K822695 (1982). 78 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 3 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 2 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 1 generation backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- This deviceK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999
- Descendant · cites it directly · 46 of its ownK100272 Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · Recalled
- Descendant · cites it directly · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- Descendant · 2 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · 3 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- Descendant · 4 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K100272Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · cites it directly46descendants
- K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · cites it directly36descendants
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 2 generations on35descendants
- K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 3 generations on24descendants
- K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −3 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −2 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −1 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | — |
| +1 | K100272 | Intellivue Clinical Information Portfolio | Philips Medical Systems | 2010 | 2 |
| +1 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| +2 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +3 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| +4 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 DXJ? 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 DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K922210 | Hewlett-Packard Model 78730 Carevue 5000Summary page 1…0 Medical cathode-ray tube display None Computers and software, medical The new device is substantially equivalent to previously cleared HP devices marketed pursuant to K922210, K922058, K990125, K984194, and KB822695. The modification is primarily a software based change that expands access to more info… | 1993 |
| * | K922058 | Models M1175A and M1176A Component Monitoring SystSummary page 1…cathode-ray tube display None Computers and software, medical The new device is substantially equivalent to previously cleared HP devices marketed pursuant to K922210, K922058, K990125, K984194, and KB822695. The modification is primarily a software based change that expands access to more information d… | 1992 |
| * | K990125 | HP Viridia Component Monitoring System, Model Rev. KSummary page 1…ray tube display None Computers and software, medical The new device is substantially equivalent to previously cleared HP devices marketed pursuant to K922210, K922058, K990125, K984194, and KB822695. The modification is primarily a software based change that expands access to more information data bases… | 1999 |
| * | K984194 | HP M2376A Device Link SystemSummary page 1…display None Computers and software, medical The new device is substantially equivalent to previously cleared HP devices marketed pursuant to K922210, K922058, K990125, K984194, and KB822695. The modification is primarily a software based change that expands access to more information data bases. Also, i… | 1999 |
| * | K822695 | Signal Distribution Network #78581ASummary page 1…mputers and software, medical The new device is substantially equivalent to previously cleared HP devices marketed pursuant to K922210, K922058, K990125, K984194, and KB822695. The modification is primarily a software based change that expands access to more information data bases. Also, improvements we… | 1982 |
What descends from it? (78)
See all 785 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100272 | Intellivue Clinical Information Portfolio | 2010 | 46 |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215… | 2011 | 36 |
| K023674 | Philips Drug Calculator Software | 2002 | 17 |
| K073372 | Electrophysiology Systems Integrator (Epsi) | 2007 | 10 |
| K012349 | Metavision Clinical Information System | 2002 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2011 | Not classified | Z-3111-2011 | Software design | Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended. |
| Mar 16, 2011 | Not classified | Z-2175-2011 | Software design | Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended. |
| Oct 19, 2010 | Not classified | Z-0414-2011 | Software design | Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours. |
| Oct 21, 2009 | Not classified | Z-0418-2010 | Software design | A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for the order may not… |
| May 5, 2009 | Not classified | Z-1654-2009 | Software design | Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a… |
| May 5, 2009 | Not classified | Z-1436-2009 | Software design | Software: A software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period |
| Mar 4, 2008 | Not classified | Z-1540-2008 | Software design | Medications prescribed for one patient were printed on the record of another patient. |
| Mar 4, 2008 | Not classified | Z-1541-2008 | Software design | Medications prescribed for one patient were printed on the record of another patient. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K100272 (Philips Medical Systems, 2010) has gone furthest, with 46 descendants of its own.
- 1 other device also cites its predicate K922210.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The HP M2331A CareVue 9000 is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.
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/K992636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992636: HP Carevue 9000 Clinical Information System, Model M2331A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992636
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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