Schneider (Europe) GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Schneider (Europe) GmbH” (first 1995, latest 1999), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 4 | 4 |
| ESW | Prosthesis, Esophageal | 1 | 1 |
Review panels
Most recent Schneider (Europe) GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984068 | FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS | ESW | 1999-01-07 | 52 |
| K982592 | DOCKING-EXTENSION WIRE | DQX | 1998-10-21 | 89 |
| K970528 | CLYDE CORONARY GUIDEWIRE | DQX | 1997-06-10 | 119 |
| K970494 | HANNIBAL GUIDEWIRE | DQX | 1997-05-09 | 88 |
| K951109 | C-THRU CORONARY GUIDE WIRE | DQX | 1995-06-08 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Schneider (Europe) GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Schneider Intl., Ltd. (22 510(k)s)
- Schneider U.S. Stent Div. (3 510(k)s)
- Schneider Stent (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Schneider (Europe) GmbH?
FDA lists 5 510(k) clearances under the applicant name “Schneider (Europe) GmbH” (first 1995, latest 1999), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Schneider (Europe) GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schneider (Europe) GmbH is 89 days.
Which FDA product codes appear under Schneider (Europe) GmbH?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 4); ESW (Prosthesis, Esophageal, 1).
Next steps
- See all 5 Schneider (Europe) GmbH clearances with predicates and recalls
- Run predicate analysis for product code DQX, Schneider (Europe) GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.