# Promedon

- Location (FDA's records): Essex Junction, VT
- FDA decisions: 2 (2002–2003): 2 510(k) clearances
- Product codes: OTN (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- American Medical Systems, Inc.: 1 (https://510kreport.com/company/american-medical-systems)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Injectx, Inc.: 1 (https://510kreport.com/company/injectx)

## Firms that cite its devices most
- Mpathy Medical Devices, Ltd.: 3 (https://510kreport.com/company/mpathy-medical-devices)
- Gyne Ideas, Ltd.: 1 (https://510kreport.com/company/gyne-ideas)
- Aspide Medical: 1 (https://510kreport.com/company/aspide-medical)

## Its most-cited devices
- K020007: Safyre Sling System (2002), cited by 6

## Recent decisions
- K033691: Safyre VS and Safyre T (Dec 19, 2003)
- K020007: Safyre Sling System (Mar 21, 2002)

Source page: https://510kreport.com/company/promedon