# K040903: Cadence, Models 2001 and 2002

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Sep 2, 2004 after 148 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: 2 generations back to K852608 (1985). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002150: Sonicaid FM820, Sonicaid FM830, Oxford Instruments (2001) Summary page 2.
- K991905: Corometrics Model 171 and 172 Fetal Monitor, General Electric Medical Systems Information Techn (1999) Summary page 2.

## Most influential descendants
- K073221: Cadence II (2007), 11 descendants of its own
- K082602: Fetal & Maternal Monitor, Model F6, F9 (2008), 6 descendants of its own
- K100797: Fetal Maternal Monitor Model F9 Express and Express (2010), 5 descendants of its own
- K082369: Cadence, Cadence Dual, Cadence II Fetal Monitor (2008), 4 descendants of its own
- K102140: Fetal Monitors, Models F2 and F3 (2011), 3 descendants of its own

## Indications for use
The Cadence Fetal Monitor, model 2001 for singletons and model 2002 for twins, is a fetal monitor for monitoring fetal well being during the antepartumn period. It performs what is commonly called the non stress test. The Cadence Fetal Monitor 2001/2002 is to be used by trained medical personnel in hospitals clinics, physicians offices, and in the patients home by prescription or doctors orders.

Source page: https://510kreport.com/device/K040903
Methodology: https://510kreport.com/methodology