Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schneider Intl., Ltd. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
174 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925406 | BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM | Schneider Intl., Ltd. | 1995-01-11 | 807 | 0 |
| K931577 | SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI | Schneider Intl., Ltd. | 1993-06-23 | 85 | 0 |
| K926003 | SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER | Schneider Intl., Ltd. | 1993-06-07 | 192 | 0 |
| K926271 | SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO | Schneider Intl., Ltd. | 1993-06-07 | 171 | 0 |
| K925804 | SCHNEIDER HYDRO-SIL GUIDEWIRE | Schneider Intl., Ltd. | 1993-02-12 | 88 | 0 |
| K924591 | SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER | Schneider Intl., Ltd. | 1992-12-08 | 89 | 0 |
| K921856 | TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. | Schneider Intl., Ltd. | 1992-07-21 | 95 | 0 |
| K921943 | SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL | Schneider Intl., Ltd. | 1992-06-17 | 54 | 0 |
| K920157 | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | Schneider Intl., Ltd. | 1992-03-16 | 62 | 0 |
| K915349 | PTA BALLOON CATHETER | Schneider Intl., Ltd. | 1992-02-11 | 77 | 0 |
| K914009 | SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER | Schneider Intl., Ltd. | 1991-12-06 | 88 | 0 |
| K913297 | SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH | Schneider Intl., Ltd. | 1991-10-10 | 78 | 0 |
| K912156 | SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE | Schneider Intl., Ltd. | 1991-09-06 | 115 | 0 |
| K912317 | SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH | Schneider Intl., Ltd. | 1991-08-22 | 90 | 0 |
| K911547 | MAGNUM-MEIER RECANALIZATION GUIDEWIRE | Schneider Intl., Ltd. | 1991-07-05 | 88 | 0 |
| K911196 | SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA) | Schneider Intl., Ltd. | 1991-06-10 | 84 | 0 |
| K910259 | SCHNEIDER MAGNARAIL PROBING CATHETER | Schneider Intl., Ltd. | 1991-04-18 | 86 | 0 |
| K902587 | SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH | Schneider Intl., Ltd. | 1990-12-03 | 174 | 0 |
| K902091 | SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER | Schneider Intl., Ltd. | 1990-09-26 | 140 | 0 |
| K897082 | SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR | Schneider Intl., Ltd. | 1990-03-06 | 76 | 0 |
| K896741 | SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH. | Schneider Intl., Ltd. | 1990-02-28 | 90 | 0 |
| K885180 | EXPANDABLE BILIARY STENT ENDOPROSTHESIS | Schneider Intl., Ltd. | 1989-02-16 | 64 | 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