Sorin Group Deutschland GmbH: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Sorin Group Deutschland GmbH” (first 2006, latest 2017), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 | 1 | 33 |
| 2014 | 2 | 162 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 113 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sorin Group Deutschland GmbH took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 8 | 8 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 3 | 3 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 | 2 |
| DXJ | Display, Cathode-Ray Tube, Medical | 2 | 2 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (20)
Most recent Sorin Group Deutschland GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170460 | Sorin Connect | DXJ | 2017-06-08 | 113 |
| K131553 | XTRA | CAC | 2014-03-21 | 295 |
| K140012 | SORIN FLEXTHERM | DWC | 2014-01-31 | 29 |
| K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | DXJ | 2013-07-23 | 33 |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | DWA | 2011-09-20 | 48 |
| K103762 | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE | DTQ | 2011-01-20 | 28 |
| K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | DWA | 2011-01-20 | 57 |
| K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | KRL | 2011-01-18 | 55 |
| K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | DRY | 2011-01-06 | 71 |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | DTX | 2010-12-09 | 239 |
10 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2017-10-30.
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.
- Sorin Group Italia S.R.L. (61 510(k)s)
- Sorin Biomedica, Fiat, USA, Inc. (20 510(k)s)
- Sorin Biomedical, Inc. (15 510(k)s)
- Sorin Group USA, Inc. (2 510(k)s)
- Sorin Biomedica Cardio S.R.L. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sorin Group Deutschland GmbH?
FDA lists 20 510(k) clearances under the applicant name “Sorin Group Deutschland GmbH” (first 2006, latest 2017), across 9 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 Sorin Group Deutschland GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sorin Group Deutschland GmbH is 78 days.
Which FDA product codes appear under Sorin Group Deutschland GmbH?
The most frequent FDA product codes under this applicant name are DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass, 8); DWA (Control, Pump Speed, Cardiopulmonary Bypass, 3); DWC (Controller, Temperature, Cardiopulmonary Bypass, 2).
Next steps
- See all 20 Sorin Group Deutschland GmbH clearances with predicates and recalls
- Run predicate analysis for product code DTQ, Sorin Group 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.