# Dacomed Corp.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 20 (1981–1995): 20 510(k) clearances
- Product codes: FAE (7), LIL (4), LKY (2), EXQ (1), FHA (1), JLW (1), KOA (1), FTQ (1), FAT (1), EWL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- American Medical Systems, Inc.: 2 (https://510kreport.com/company/american-medical-systems)
- Plethora Solutions: 2 (https://510kreport.com/company/plethora-solutions)
- Timm Research Co.: 1 (https://510kreport.com/company/timm-research)
- Uromed Corp.: 1 (https://510kreport.com/company/uromed)
- Urometrics, Inc.: 1 (https://510kreport.com/company/urometrics)
- Imagyn Medical Technologies, Inc.: 1 (https://510kreport.com/company/imagyn-medical-technologies)

## Its most-cited devices
- K941781: Rigiscan Plus Rigidity Assessment System (1994), cited by 2
- K885323: Dacomed External Male Continence Device (1989), cited by 2
- K953640: Duna II Penile Prosthesis (1995), cited by 2
- K920409: Dacomed Battery Operated Vacuum Erection Device (1992), cited by 1
- K841202: Dacomed Rigiscan System (1984), cited by 1

## Recent decisions
- K953640: Duna II Penile Prosthesis (Oct 27, 1995)
- K941781: Rigiscan Plus Rigidity Assessment System (Aug 25, 1994)
- K920409: Dacomed Battery Operated Vacuum Erection Device (May 11, 1992)
- K920420: Dura II Penile Prosthesis (Apr 16, 1992)
- K912344: Modified Duraphase (TM) Implanted Penile Prosthesis (Oct 11, 1991)
- K900774: Dacomed Negative Pressure Erection Device (May 4, 1990)
- K885323: Dacomed External Male Continence Device (Feb 8, 1989)
- K880391: Dacomed Cystometer (Apr 27, 1988)

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