510(k) Report

FDA applicant

Dacomed Corp.

Minneapolis, MN20 decisions1981–19952 recalls

FDA records 20 decisions for Dacomed Corp. (Minneapolis, MN) from 1981 to 1995: 20 510(k) clearances. Most are in product codes FAE (Prosthesis, Penile) and LIL (Monitor, Penile Tumescence). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Dacomed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dacomed Corp. since 2007.

Recalls per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Dacomed Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FAEProsthesis, Penile7decisions
  • LILMonitor, Penile Tumescence4decisions
  • LKYDevice, External Penile Rigidity2decisions
  • EXQCystometer, Electrical Recording1decision
  • FHAClamp, Penile1decision
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone1decision

Also: KOA (1), FTQ (1), FAT (1), EWL (1).

Who builds on its devices?

Later devices cite its devices 8 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K941781Rigiscan Plus Rigidity Assessment SystemDacomed Corp. · 19942cite it
  • K885323Dacomed External Male Continence DeviceDacomed Corp. · 19892cite it
  • K953640Duna II Penile ProsthesisDacomed Corp. · 19952cite it
  • K920409Dacomed Battery Operated Vacuum Erection DeviceDacomed Corp. · 19921cites it
  • K841202Dacomed Rigiscan SystemDacomed Corp. · 19841cites it

What has FDA decided for it lately?

  • K953640Duna II Penile ProsthesisDacomed Corp. · 19952 recalls
  • K941781Rigiscan Plus Rigidity Assessment SystemDacomed Corp. · 1994
  • K920409Dacomed Battery Operated Vacuum Erection DeviceDacomed Corp. · 1992
  • K920420Dura II Penile ProsthesisDacomed Corp. · 1992
  • K912344Modified Duraphase (TM) Implanted Penile ProsthesisDacomed Corp. · 1991
  • K900774Dacomed Negative Pressure Erection DeviceDacomed Corp. · 1990
  • K885323Dacomed External Male Continence DeviceDacomed Corp. · 1989
  • K880391Dacomed CystometerDacomed Corp. · 1988

All 20 as Dacomed Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K953640AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical…Feb 19, 2007
  • K953640AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical…Feb 19, 2007