# K073221: Cadence II

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 28, 2007 after 43 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: 3 generations back to K852608 (1985). 5 ancestors in all.
11 later devices descend from it; 3 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)
- K040903: Cadence, Models 2001 and 2002, Edan Instruments, Inc. (2004) Summary page 2.

## Most influential descendants
- 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
- K150901: Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express (2015), 2 descendants of its own

## Indications for use
The CADENCEII fetal monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It 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/K073221
Methodology: https://510kreport.com/methodology