Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Urology Group — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
223 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831703 | COVERUPS | The Urology Group | 1984-01-03 | 223 | 0 |
| K831489 | SURGICAL TUBE HOLDER | The Urology Group | 1983-12-12 | 216 | 0 |
| K810739 | SUCTION WOUND DRAINAGE DEVICE | The Urology Group | 1981-06-26 | 99 | 0 |
| K810788 | SURGICAL TUBE HOLDER | The Urology Group | 1981-04-17 | 25 | 0 |
| K810787 | UROLOGIC TUBE HOLDER | The Urology Group | 1981-03-31 | 8 | 0 |
| K801629 | COVER-ALL MALE INCONTINENCE DEVICE | The Urology Group | 1980-08-12 | 28 | 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