# K112159: CMS-1000FM Central Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Sep 21, 2011 after 56 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: 1 generation back to K100358 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100358: Central Monitoring System, Edan Instruments, Inc. (2011) Summary page 2.

## Indications for use
The CMS-1000FM Central Monitoring System (hereinafter called "OMS-IOOOFM") is a clinical data managing software application and is indicated for antepartumn and intrapartumn monitoring of pregnant women in a healthcare setting. The CMS-1000FM is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record. The CMS-1000FM has display fields for the following obstetric data: patient demographics provider notes FHR uterine activity (via tocodynamometry or IUP) maternal heart rate SpO 2 NIBP respiratory rate temperature pulse rate

Source page: https://510kreport.com/device/K112159
Methodology: https://510kreport.com/methodology