Stoeckert Instrumente: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Stoeckert Instrumente” (first 1982, latest 2001), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 187 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 3 | 3 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 2 | 2 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (13)
Most recent Stoeckert Instrumente 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002273 | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE | DWF | 2001-01-29 | 187 |
| K001961 | STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE | DWF | 2001-01-25 | 212 |
| K002118 | STOCKERT COMPACT SYSTEM VERSION 2.0 | DTQ | 2000-08-09 | 27 |
| K992635 | INTERFACE MODULE IDDD | KRI | 1999-12-20 | 136 |
| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | KRI | 1999-11-23 | 278 |
| K982014 | STOCKERT COMPACT SYSTEM | DTQ | 1998-09-04 | 88 |
| K972321 | S3 MAST PUMP | DWB | 1998-02-27 | 249 |
| K971520 | S3 CYCLIC RPM CONTROL | DWB | 1997-09-10 | 138 |
| K962320 | S3 CARDIOPLEGIA CONTROL | DTR | 1997-01-10 | 207 |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | DTW | 1996-02-22 | 101 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stoeckert Instrumente.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Stoeckert Instrumente?
FDA lists 13 510(k) clearances under the applicant name “Stoeckert Instrumente” (first 1982, latest 2001), across 7 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 Stoeckert Instrumente?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stoeckert Instrumente is 187 days.
Which FDA product codes appear under Stoeckert Instrumente?
The most frequent FDA product codes under this applicant name are DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass, 3); DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type, 3); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2).
Next steps
- See all 13 Stoeckert Instrumente clearances with predicates and recalls
- Run predicate analysis for product code DTQ, Stoeckert Instrumente'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.