Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FAH · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933957 | DILATING URETHRAL SOUND | Cook Urological, Inc. | 1993-11-17 | 97 | 0 |
| K902370 | MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER | Boston Scientific Corp | 1990-08-17 | 80 | 0 |
| K902124 | DOWD CATHETER | Boston Scientific Corp | 1990-08-09 | 90 | 0 |
| K831384 | COAXIAL BALLOON URETHRAL DILATOR | Thomas J. Fogarty, M.D. | 1983-07-26 | 89 | 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