# K082602: Fetal & Maternal Monitor, Model F6, F9

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Nov 26, 2008 after 79 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). 12 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K073221: Cadence II, Edan Instruments, Inc. (2007) Summary page 1.
- K991739: Corometrics 120 Series Maternal/Fetal Monitor, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Most influential descendants
- K100797: Fetal Maternal Monitor Model F9 Express and Express (2010), 5 descendants of its own
- 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

## Indications for use
The Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

Source page: https://510kreport.com/device/K082602
Methodology: https://510kreport.com/methodology