Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schneider-Shilley (Usa) · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
224 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882826 | SOFTRAC-PTA PERIPHERAL DILATATION CATHETER | Schneider-Shilley (Usa) | 1989-01-24 | 200 | 0 |
| K875175 | MODIFIED PERIPHERAL DILATATION CATHETERS | Schneider-Shilley (Usa) | 1988-07-28 | 224 | 0 |
| K881197 | SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER | Schneider-Shilley (Usa) | 1988-05-16 | 56 | 0 |
| K875322 | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | Schneider-Shilley (Usa) | 1988-03-28 | 90 | 0 |
| K875323 | MODIFIED SCHNEIDER-SHILEY WIRE TORQUER | Schneider-Shilley (Usa) | 1988-03-28 | 90 | 0 |
| K875324 | MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES | Schneider-Shilley (Usa) | 1988-03-25 | 87 | 0 |
| K875327 | MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT | Schneider-Shilley (Usa) | 1988-03-25 | 87 | 0 |
| K875325 | MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK | Schneider-Shilley (Usa) | 1988-02-18 | 51 | 0 |
| K875326 | MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER | Schneider-Shilley (Usa) | 1988-02-18 | 51 | 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