Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dacomed Corp. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
159 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953640 | DUNA II PENILE PROSTHESIS | Dacomed Corp. | 1995-10-27 | 84 | 2 |
| K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | Dacomed Corp. | 1994-08-25 | 136 | 0 |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | Dacomed Corp. | 1992-05-11 | 101 | 0 |
| K920420 | DURA II PENILE PROSTHESIS | Dacomed Corp. | 1992-04-16 | 76 | 0 |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Dacomed Corp. | 1991-10-11 | 136 | 0 |
| K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE | Dacomed Corp. | 1990-05-04 | 73 | 0 |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Dacomed Corp. | 1989-02-08 | 42 | 0 |
| K880391 | DACOMED CYSTOMETER | Dacomed Corp. | 1988-04-27 | 89 | 0 |
| K871653 | DURAPHASE PENILE PROSTHESIS | Dacomed Corp. | 1987-09-18 | 143 | 0 |
| K870320 | DACOMED PENILE PROSTHESIS SIZER | Dacomed Corp. | 1987-03-17 | 48 | 0 |
| K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS | Dacomed Corp. | 1986-03-17 | 159 | 0 |
| K850019 | OMNI PHASE PENILE PROSTHESIS | Dacomed Corp. | 1985-04-09 | 96 | 0 |
| K843186 | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | Dacomed Corp. | 1985-01-18 | 158 | 0 |
| K841202 | DACOMED RIGISCAN SYSTEM | Dacomed Corp. | 1984-07-06 | 107 | 0 |
| K834504 | ESKA JONAS SILICON-SILVER PENILE | Dacomed Corp. | 1984-02-04 | 45 | 0 |
| K830667 | SILICONE-SILVER PENILE PROSTHESIS-ESK | Dacomed Corp. | 1983-10-20 | 230 | 0 |
| K832121 | DACOMED SNAP-GAUGE | Dacomed Corp. | 1983-07-18 | 18 | 0 |
| K820615 | DACOMED SNAP-GAUGE | Dacomed Corp. | 1982-04-21 | 44 | 0 |
| K820081 | ESKA JONAS SILICONE-SILVER PENILE PROST | Dacomed Corp. | 1982-01-25 | 13 | 0 |
| K811693 | FORDER RETRACTOR | Dacomed Corp. | 1981-06-26 | 11 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda