# K100797: Fetal Maternal Monitor Model F9 Express and Express

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Nov 10, 2010 after 233 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: 5 generations back to K852608 (1985). 13 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082602: Fetal & Maternal Monitor, Model F6, F9, Edan Instruments, Inc. (2008) Summary page 1.
- K991739: Corometrics 120 Series Maternal/Fetal Monitor, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Most influential descendants
- K150901: Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express (2015), 2 descendants of its own
- K173042: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (2018), 1 descendant of its own
- K241882: Fetal & Maternal Monitor (F15A, F15A Air) (2025), 0 descendants of its own
- K131941: Fetal Monitors (2014), 0 descendants of its own
- K112317: FM-9000 Plus Fetal and Maternal Monitor (2011), 0 descendants of its own

## Indications for use
F6 Express and F9 Express fetal & maternal monitor is intended for monitoring physiological parameters of pregnant women during ante-partum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in ante- partum examination rooms, labor and delivery rooms. F6 Express and F9 Express fetal & maternal monitor is intended for providing Non- Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

Source page: https://510kreport.com/device/K100797
Methodology: https://510kreport.com/methodology