Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uromed Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
323 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010213 | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | 2001-04-20 | 87 | 0 |
| K010098 | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | 2001-02-01 | 21 | 0 |
| K000507 | CAVERMAP SURGICAL AID | Uromed Corp. | 2000-04-21 | 66 | 1 |
| K993436 | CAVERMAP SURGICAL AID | Uromed Corp. | 2000-02-11 | 122 | 1 |
| K982226 | UROMED BRACHYTHERAPHY IODINE-125 SOURCES | Uromed Corp. | 1999-05-13 | 323 | 0 |
| K980717 | UROMED SLING KIT | Uromed Corp. | 1998-05-22 | 87 | 0 |
| K974600 | UROMED PATCH | Uromed Corp. | 1998-03-31 | 112 | 0 |
| K974137 | UROMED NEEDLE GRASPER | Uromed Corp. | 1998-01-30 | 88 | 0 |
| K970971 | URO MED NERVE STIMULATOR | Uromed Corp. | 1997-10-27 | 224 | 0 |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0 | Uromed Corp. | 1997-08-01 | 64 | 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