Schneider Intl., Ltd.: FDA clearances and approvals
Schneider Intl., Ltd. has 22 FDA 510(k) clearances (first 1989, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time: 88 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 | 8 | 8 |
| DQO | Catheter, Intravascular, Diagnostic | 4 | 4 |
| DQX | Wire, Guide, Catheter | 4 | 4 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 | 1 |
Review panels
Most recent Schneider Intl., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925406 | BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM | FGE | 1995-01-11 | 807 |
| K931577 | SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI | DQX | 1993-06-23 | 85 |
| K926271 | SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO | LIT | 1993-06-07 | 171 |
| K926003 | SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER | DQO | 1993-06-07 | 192 |
| K925804 | SCHNEIDER HYDRO-SIL GUIDEWIRE | DQX | 1993-02-12 | 88 |
| K924591 | SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER | DQY | 1992-12-08 | 89 |
| K921856 | TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. | LIT | 1992-07-21 | 95 |
| K921943 | SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL | LIT | 1992-06-17 | 54 |
| K920157 | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | DXY | 1992-03-16 | 62 |
| K915349 | PTA BALLOON CATHETER | LIT | 1992-02-11 | 77 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Schneider Intl., Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Schneider Intl., Ltd.'s product codes (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances does Schneider Intl., Ltd. have?
Schneider Intl., Ltd. has 22 FDA 510(k) clearances (first 1989, latest 1995), across 6 product codes in 2 review panels.
How long does FDA take to clear Schneider Intl., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Schneider Intl., Ltd.'s cleared 510(k)s is 88 days.
What devices does Schneider Intl., Ltd. make?
Its most frequent FDA product codes are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 8); DQO (Catheter, Intravascular, Diagnostic, 4); DQX (Wire, Guide, Catheter, 4).
Has Schneider Intl., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Schneider Intl., Ltd. Related entities may recall under other names.
Next steps
- See all 22 Schneider Intl., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Schneider Intl., Ltd.'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.