# K921682: Zinetics Amc

- Pathway: 510(k) (Traditional)
- Applicant: Zinetics Medical, Inc.
- Decided: Dec 29, 1994 after 995 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K032138: Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter (2003), 1 descendant of its own
- K062362: Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K921682
Methodology: https://510kreport.com/methodology