# K102263: Horizon Perinatal Care Surveillance and Archival Model Verson 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Mckesson Information Solutions, LLC
- Decided: May 5, 2011 after 268 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833395 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980719: CALM, Lms Medical Systems, Ltd. (1998) Summary page 1.

## Indications for use
Horizon Perinatal Care Surveillance and Archival System is intended for use as a central monitoring system, providing fetal surveillance and monitoring of multiple obstetrical and fetal patients simultaneously and to correlate pertinent patient observations of physiological parameters Interfaces with fetal and maternal monitors to provide fetal surveillance, monitoring of labor progress, display and archiving functions Allow care givers to electronically document and store patient information on obstetrical patients in a health care facility; and Provides remote access to the HPC S&A system.

Source page: https://510kreport.com/device/K102263
Methodology: https://510kreport.com/methodology