Loredan Biomedical, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Loredan Biomedical, Inc.” (first 1983, latest 1993), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | 7 | 7 |
| BXB | Exerciser, Powered | 1 | 1 |
| LXJ | Interactive Rehabilitation Exercise Devices | 1 | 1 |
Review panels
Most recent Loredan Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924512 | LIDO V-TAK | LXJ | 1993-05-12 | 250 |
| K924513 | LIDO(R) LINEA | BXB | 1993-03-31 | 208 |
| K903429 | LIDO LINEA | IKK | 1990-08-14 | 14 |
| K884487 | LIDO TM ACTIVE BACK | IKK | 1988-11-18 | 24 |
| K880018 | LIDO(TM) WORKSET | IKK | 1988-02-26 | 52 |
| K880017 | LIDO(TM) LIFT | IKK | 1988-02-26 | 52 |
| K871793 | LIDO ACTIVE | IKK | 1987-06-05 | 29 |
| K861986 | LIDO BACK | IKK | 1986-06-02 | 11 |
| K832770 | LANE ONE | IKK | 1983-09-26 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Loredan 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Loredan Biomedical, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Loredan Biomedical, Inc.” (first 1983, latest 1993), across 3 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 Loredan Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Loredan Biomedical, Inc. is 41 days.
Which FDA product codes appear under Loredan Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are IKK (System, Isokinetic Testing And Evaluation, 7); BXB (Exerciser, Powered, 1); LXJ (Interactive Rehabilitation Exercise Devices, 1).
Next steps
- See all 9 Loredan Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IKK, Loredan 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, 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.