# K992636: HP Carevue 9000 Clinical Information System, Model M2331A

- Pathway: 510(k) (Special)
- Applicant: Hewlett-Packard Co.
- Decided: Aug 31, 1999 after 25 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941811 (1994). 14 ancestors in all.
78 later devices descend from it; 5 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922210: Hewlett-Packard Model 78730 Carevue 5000, Hewlett-Packard Co. (1993) Summary page 1.
- K922058: Models M1175A and M1176A Component Monitoring Syst, Hewlett-Packard Co. (1992) Summary page 1.
- K990125: HP Viridia Component Monitoring System, Model Rev. K, Hewlett-Packard GmbH (1999) Summary page 1.
- K984194: HP M2376A Device Link System, Hewlett-Packard Co. (1999) Summary page 1.
- K822695: Signal Distribution Network #78581A, Hewlett-Packard Co. (1982) Summary page 1.

## Most influential descendants
- K100272: Intellivue Clinical Information Portfolio (2010), 46 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own

## Recalls of this device
- Jul 8, 2011 · Not classified · Z-3111-2011: 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 medi
- Mar 16, 2011 · Not classified · Z-2175-2011: 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: 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 bei
- Oct 21, 2009 · Not classified · Z-0418-2010: 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 
- May 5, 2009 · Not classified · Z-1654-2009: 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 
- May 5, 2009 · Not classified · Z-1436-2009: 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: Medications prescribed for one patient were printed on the record of another patient.
- Mar 4, 2008 · Not classified · Z-1541-2008: Medications prescribed for one patient were printed on the record of another patient.

## Indications for use
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.

Source page: https://510kreport.com/device/K992636
Methodology: https://510kreport.com/methodology