Sorin Group USA, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Sorin Group USA, Inc.” (first 2010, latest 2013), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 141 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 | 257 |
| 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 0 |
Review panels
Most recent Sorin Group USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122735 | SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 | GAT | 2013-05-21 | 257 |
| K102983 | VASCUCLEAR PRECISION BIPOLAR | GEI | 2010-11-01 | 25 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850063 | PMA | MICRO YAG ND:YAG LASER SYSTEM | 1986-01-31 |
Recalls
135 product recalls in 28 recall events; 0 initiated in the last five years. Most recent: 2017-09-28.
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.
Device clinical trials
An industry sponsor named Sorin Group USA, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01115907: Freedom SOLO Stentless Heart Valve Study (Completed, started 2010-12)
- NCT00567853: Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair (Completed, started 2007-08)
- NCT00630916: Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve (Completed, started 2003-11)
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 Biomedical, Inc. (15 510(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 USA, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Sorin Group USA, Inc.” (first 2010, latest 2013), plus 1 PMA decision, across 3 product codes in 2 review panels. 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 USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sorin Group USA, Inc. is 141 days.
Which FDA product codes appear under Sorin Group USA, Inc.?
The most frequent FDA product codes under this applicant name are GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); LOI (Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary, 1).
Next steps
- See all 2 Sorin Group USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAT, Sorin Group USA, 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, 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.