Leventon, S.A.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Leventon, S.A.” (first 1985, latest 2005), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
Review panels
- General Hospital (3)
- Anesthesiology (2)
Most recent Leventon, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053149 | SPIRO-BALL | BWF | 2005-12-13 | 33 |
| K040752 | DOSI-FUSER | MEB | 2004-04-07 | 14 |
| K994074 | TRI-BALL | BWF | 2000-06-08 | 189 |
| K952810 | DOSI-FLOW, MODELS 20 & 30 | FPA | 1995-09-08 | 81 |
| K851058 | DOSI FLOW | LDR | 1985-04-29 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named Leventon, S.A..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Leventon, S.A. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Frequently asked questions
How many FDA 510(k) clearances are listed under Leventon, S.A.?
FDA lists 5 510(k) clearances under the applicant name “Leventon, S.A.” (first 1985, latest 2005), across 4 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 Leventon, S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Leventon, S.A. is 46 days.
Which FDA product codes appear under Leventon, S.A.?
The most frequent FDA product codes under this applicant name are BWF (Spirometer, Therapeutic (Incentive), 2); FPA (Set, Administration, Intravascular, 1); LDR (Controller, Infusion, Intravascular, Electronic, 1).
Next steps
- See all 5 Leventon, S.A. clearances with predicates and recalls
- Run predicate analysis for product code BWF, Leventon, S.A.'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.