Stockert Instrumente GmbH: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Stockert Instrumente GmbH” (first 2001, latest 2004), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 3 | 3 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | 2 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent Stockert Instrumente GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042374 | STOCKERT SCP RHYTHM | DWA | 2004-09-23 | 22 |
| K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM | DTW | 2004-07-02 | 22 |
| K032213 | STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP | DWA | 2003-08-29 | 39 |
| K023622 | STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 | DWF | 2002-11-21 | 23 |
| K022280 | STOCKERT CORONARY PERFUSION CANNULAE | DWF | 2002-10-11 | 88 |
| K022321 | STOCKERT V172-28 VENOUS FEMORAL CANNULA | DWF | 2002-10-09 | 84 |
| K020571 | STOCKERT CENTRIFUGAL PUMP CONSOLE | DTQ | 2002-09-23 | 214 |
| K011838 | CENTRIFUGAL PUMP | DWA | 2002-02-05 | 238 |
| K011088 | SIII ALARM AMPLIFIER | DTQ | 2001-05-02 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Stockert Instrumente 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 GmbH (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stockert Instrumente GmbH?
FDA lists 9 510(k) clearances under the applicant name “Stockert Instrumente GmbH” (first 2001, latest 2004), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stockert Instrumente GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stockert Instrumente GmbH is 39 days.
Which FDA product codes appear under Stockert Instrumente GmbH?
The most frequent FDA product codes under this applicant name are DWA (Control, Pump Speed, Cardiopulmonary Bypass, 3); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 3); DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass, 2).
Next steps
- See all 9 Stockert Instrumente GmbH clearances with predicates and recalls
- Run predicate analysis for product code DWA, Stockert Instrumente 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.