Jostra AG: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Jostra AG” (first 2000, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 9 | 9 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 | 1 |
Review panels
- Cardiovascular (13)
Most recent Jostra AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020983 | JOSTRA SUCKERS, MODEL JS | DWF | 2004-01-30 | 674 |
| K030264 | QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 | DTZ | 2003-02-26 | 30 |
| K020784 | JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS | DWF | 2003-01-09 | 304 |
| K023132 | JOSTRA MECC SYSTEM | KFM | 2002-12-17 | 88 |
| K022022 | JOSTRA VENT CATHETERS, MODELS LV & HKV | DWF | 2002-09-11 | 83 |
| K020515 | JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA | DWF | 2002-04-24 | 68 |
| K014303 | JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE | DWF | 2002-03-26 | 85 |
| K013944 | JOSTRA DUAL STAGE VENOUS RETURN CANNULAE | DWF | 2002-02-11 | 74 |
| K013939 | JOSTRA FLOWPROBE FP-32E | DPT | 2001-12-14 | 15 |
| K012774 | JOSTRA ARTERIAL PERFUSION CANNULAE | DWF | 2001-11-16 | 88 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jostra AG.
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.
- Jostra Bentley (3 510(k)s)
- Jostra Medizintechnik AG (2 510(k)s)
- Jostra AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jostra AG?
FDA lists 13 510(k) clearances under the applicant name “Jostra AG” (first 2000, latest 2004), across 5 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 Jostra AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jostra AG is 85 days.
Which FDA product codes appear under Jostra AG?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 9); DPT (Probe, Blood-Flow, Extravascular, 1); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 1).
Next steps
- See all 13 Jostra AG clearances with predicates and recalls
- Run predicate analysis for product code DWF, Jostra AG'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.