Schneider-Shilley (Usa): FDA clearances and approvals
Schneider-Shilley (Usa) has 9 FDA 510(k) clearances (first 1988, latest 1989), across 6 product codes in 2 review panels. Median 510(k) review time: 87 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| KRK | Manometer, Blood-Pressure, Venous | 1 | 1 |
Review panels
- Cardiovascular (8)
- General Hospital (1)
Most recent Schneider-Shilley (Usa) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882826 | SOFTRAC-PTA PERIPHERAL DILATATION CATHETER | LIT | 1989-01-24 | 200 |
| K875175 | MODIFIED PERIPHERAL DILATATION CATHETERS | LIT | 1988-07-28 | 224 |
| K881197 | SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER | LIT | 1988-05-16 | 56 |
| K875323 | MODIFIED SCHNEIDER-SHILEY WIRE TORQUER | DQX | 1988-03-28 | 90 |
| K875322 | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | KRK | 1988-03-28 | 90 |
| K875327 | MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT | DRE | 1988-03-25 | 87 |
| K875324 | MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES | DXT | 1988-03-25 | 87 |
| K875326 | MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER | DQO | 1988-02-18 | 51 |
| K875325 | MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK | DQO | 1988-02-18 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Schneider-Shilley (Usa).
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Schneider-Shilley (Usa) have?
Schneider-Shilley (Usa) has 9 FDA 510(k) clearances (first 1988, latest 1989), across 6 product codes in 2 review panels.
How long does FDA take to clear Schneider-Shilley (Usa)'s 510(k)s?
The median time from FDA receipt to decision across Schneider-Shilley (Usa)'s cleared 510(k)s is 87 days.
What devices does Schneider-Shilley (Usa) make?
Its most frequent FDA product codes are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 3); DQO (Catheter, Intravascular, Diagnostic, 2); DQX (Wire, Guide, Catheter, 1).
Has Schneider-Shilley (Usa) had device recalls?
openFDA lists no recalls under a recalling firm name matching Schneider-Shilley (Usa). Related entities may recall under other names.
Next steps
- See all 9 Schneider-Shilley (Usa) clearances with predicates and recalls
- Run predicate analysis for product code LIT, Schneider-Shilley (Usa)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.