# K112187: FM-1000 Plus Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Sep 21, 2011 after 54 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 K852608 (1985). 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)
- K073221: Cadence II, Edan Instruments, Inc. (2007) Summary page 2.

## Indications for use
The FM-10OO Plus Fetal Monitor is used to monitor fetal well being during the antepartumn period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physician's offices and in the patient's home by prescription or doctors orders.

Source page: https://510kreport.com/device/K112187
Methodology: https://510kreport.com/methodology