Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Urology, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
315 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921838 | ACUCISE URETERAL CUTTING CATHETER | Applied Urology, Inc. | 1993-02-26 | 315 | 0 |
| K925282 | UROLOGICAL CATHETER AND ACCESSORIES | Applied Urology, Inc. | 1993-01-13 | 85 | 0 |
| K920695 | URETERAL STENT | Applied Urology, Inc. | 1992-09-23 | 222 | 0 |
| K915219 | URETHRAL ELECTRODE SHEATH | Applied Urology, Inc. | 1992-07-23 | 246 | 0 |
| K912093 | DISPOSABLE ASPIRATION IRRIGATION SYSTEM | Applied Urology, Inc. | 1992-04-24 | 346 | 0 |
| K920030 | SURESEAL ENDOSCOPIC VALVE | Applied Urology, Inc. | 1992-03-18 | 75 | 0 |
| K912656 | ENDOSCOPIC ELECTRODE | Applied Urology, Inc. | 1991-09-16 | 91 | 0 |
| K912903 | PERCUTANEOUS RETRACTOR KIT | Applied Urology, Inc. | 1991-08-16 | 45 | 0 |
| K905731 | FLEXIBLE ENDOSCOPIC ELECTRODE | Applied Urology, Inc. | 1991-01-31 | 38 | 0 |
| K903994 | URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION | Applied Urology, Inc. | 1990-10-19 | 51 | 0 |
| K901214 | RIGID URETEROSCOPE | Applied Urology, Inc. | 1990-06-01 | 79 | 0 |
| K900781 | WORKING CHANNEL VALVE | Applied Urology, Inc. | 1990-04-25 | 64 | 0 |
| K896385 | URETERAL ACCESS SET | Applied Urology, Inc. | 1990-01-22 | 77 | 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