# K964122: HP Star ST and Arrhhythmia Software

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Jan 8, 1997 after 85 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
456 later devices descend from it; 8 cite it directly.
0 of 457 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K991773: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P (1999), 455 descendants of its own
- K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B (2001), 431 descendants of its own
- K021300: Modification of Philips Component Compact Monitor, Release a.03, Model M1275B (2002), 421 descendants of its own
- K020531: Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B (2002), 416 descendants of its own
- K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B (2002), 407 descendants of its own

## Indications for use
The indications for use of the STAR ST and Arrhythmia algorithm software device are: Condition: the clinician decides to continuously monitor cardiac arrhythmia and / or ST segment. Part of body or type of tissue interacted with: ECG signal obtained from electrodes attached to the skin of adult, pediatric, and neonatal patients Frequency of use: As prescribed by clinician. Physiological purpose: To gain information for treatment or to rule out causes of symptoms. Prescription versus over-the-counter: STAR is a prescription device

Source page: https://510kreport.com/device/K964122
Methodology: https://510kreport.com/methodology