Stockert GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Stockert GmbH” (first 2001, latest 2007), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 129 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 LivaNova, 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 |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | 4 | 4 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
Review panels
- Anesthesiology (4)
- Neurology (1)
Most recent Stockert GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070336 | STOCKERT NEURO N50, MODEL12267 | GXD | 2007-06-14 | 129 |
| K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | BXN | 2007-03-22 | 65 |
| K061983 | STIMUPLEX PEN | BXN | 2006-11-21 | 131 |
| K052313 | STIMUPLEX HNS-12, MODEL 4892098 | BXN | 2005-11-17 | 84 |
| K003983 | STIMUPLEX HNS-11 | BXN | 2001-06-06 | 162 |
Recalls
openFDA lists no recalls under a recalling firm named Stockert 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.
- Stockert Instrumente GmbH (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stockert GmbH?
FDA lists 5 510(k) clearances under the applicant name “Stockert GmbH” (first 2001, latest 2007), 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 Stockert GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stockert GmbH is 129 days.
Which FDA product codes appear under Stockert GmbH?
The most frequent FDA product codes under this applicant name are BXN (Stimulator, Nerve, Battery-Powered, 4); GXD (Generator, Lesion, Radiofrequency, 1).
Next steps
- See all 5 Stockert GmbH clearances with predicates and recalls
- Run predicate analysis for product code BXN, Stockert 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.