# K082369: Cadence, Cadence Dual, Cadence II Fetal Monitor

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Nov 7, 2008 after 81 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.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040903: Cadence, Models 2001 and 2002, Edan Instruments, Inc. (2004) Summary page 2.
- K073221: Cadence II, Edan Instruments, Inc. (2007) Summary page 2.

## Most influential descendants
- K102140: Fetal Monitors, Models F2 and F3 (2011), 3 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
- K141194: FM-3000 Fetal Monitor (2014), 0 descendants of its own

## Indications for use
Cadence series Fetal monitor is intended for monitoring physiological parameters of pregnant women 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. It is not intended for use in intensive care units, operating rooms or for home use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Source page: https://510kreport.com/device/K082369
Methodology: https://510kreport.com/methodology