# K002150: Sonicaid FM820, Sonicaid FM830

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Instruments
- Decided: Mar 9, 2001 after 235 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
No predicates in its family tree.
18 later devices descend from it; 2 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040903: Cadence, Models 2001 and 2002 (2004), 12 descendants of its own
- 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
- K090285: Sonicaid FM820 and FM830 Encore (2009), 4 descendants of its own

Source page: https://510kreport.com/device/K002150
Methodology: https://510kreport.com/methodology