Livanova Deutschland, GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Livanova Deutschland, GmbH” (first 2020, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 241 days. Since 2017 the median was 241 days, against 126 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2020 | 1 | 277 |
| 2021 | 3 | 135 |
| 2022 | 1 | 257 |
| 2023 | 2 | 162 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Livanova Deutschland, GmbH took a median 241 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 3 | 3 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Livanova Deutschland, GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | DTQ | 2023-08-24 | 23 |
| K221373 | Essenz HLM | DTQ | 2023-03-09 | 301 |
| K220635 | Heater-Cooler System 3T | DWC | 2022-11-16 | 257 |
| K212003 | ESSENZ Patient Monitor | DXJ | 2021-11-10 | 135 |
| K210130 | Stockert S5 System | DTQ | 2021-04-05 | 76 |
| K202154 | B-Capta | DRY | 2021-04-01 | 241 |
| K191402 | Heater-Cooler System 3T | DWC | 2020-02-25 | 277 |
Recalls
5 product recalls in 4 recall events; 3 initiated in the last five years. Most recent: 2024-10-18.
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.
- LivaNova USA, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Livanova Deutschland, GmbH?
FDA lists 7 510(k) clearances under the applicant name “Livanova Deutschland, GmbH” (first 2020, latest 2023), 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 Livanova Deutschland, GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Livanova Deutschland, GmbH is 241 days. Since 2017: 241 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Livanova Deutschland, GmbH?
The most frequent FDA product codes under this applicant name are DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass, 3); DWC (Controller, Temperature, Cardiopulmonary Bypass, 2); DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, 1).
Next steps
- See all 7 Livanova Deutschland, GmbH clearances with predicates and recalls
- Run predicate analysis for product code DTQ, Livanova Deutschland, 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.