Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GBO — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
91 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041995 | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI- | Uresil, LLC | 2004-08-19 | 27 | 0 |
| K021632 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE | Uresil, L.P. | 2002-06-13 | 27 | 0 |
| K912109 | URESIL GENERAL PURPOSE DRAINAGE CATHETER | Uresil Corp. | 1991-08-12 | 91 | 0 |
| K854911 | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) | Angiomed U.S., Inc. | 1986-01-24 | 46 | 0 |
| K854909 | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS | Angiomed U.S., Inc. | 1986-01-24 | 46 | 0 |
| K854905 | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | Angiomed U.S., Inc. | 1986-01-24 | 46 | 0 |
| K854906 | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | Angiomed U.S., Inc. | 1986-01-24 | 0 | 0 |
| K854907 | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) | Angiomed U.S., Inc. | 1986-01-24 | 46 | 0 |
| K820867 | PERCUTANEOUS NEPHROSTOMY SET | Van-Tec, Inc. | 1982-04-13 | 15 | 4 |
| K781664 | SILASTIC NEPHROSTOMY SYSTEM | Dow Corning Corp. Healthcare Industries Materials | 1979-01-22 | 116 | 0 |
| K781526 | SILASTIC U-TUBE KIT | Dow Corning Corp. Healthcare Industries Materials | 1978-09-20 | 15 | 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