Sorin Biomedical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Sorin Biomedical, Inc.” (first 1993, latest 1999), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 240 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 8 | 8 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (15)
Most recent Sorin Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990103 | MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE | DTZ | 1999-11-05 | 297 |
| K963759 | DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS | CAC | 1998-02-20 | 520 |
| K963758 | CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE | CAC | 1998-02-20 | 520 |
| K964908 | VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER | DTN | 1997-09-03 | 268 |
| K964907 | VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT | DTN | 1997-08-21 | 255 |
| K961869 | DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 | DTM | 1996-08-12 | 89 |
| K952270 | DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN | DTM | 1995-08-21 | 98 |
| K945198 | DIDECO PEDIATRIC ARTERIAL FILTERS | DTM | 1995-06-27 | 246 |
| K945065 | DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 | DTN | 1995-05-19 | 217 |
| K941215 | VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR | DTN | 1995-05-10 | 426 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sorin Biomedical, Inc..
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 Group Deutschland GmbH (20 510(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 Biomedical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Sorin Biomedical, Inc.” (first 1993, latest 1999), 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 Sorin Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sorin Biomedical, Inc. is 240 days.
Which FDA product codes appear under Sorin Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are DTN (Reservoir, Blood, Cardiopulmonary Bypass, 8); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 3); CAC (Apparatus, Autotransfusion, 2).
Next steps
- See all 15 Sorin Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTN, Sorin Biomedical, Inc.'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.