Lucas Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Lucas Medical, Inc.” (first 1996, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 130 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | 4 | 4 |
| MJN | Catheter, Intravascular Occluding, Temporary | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
Review panels
Most recent Lucas Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983802 | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB | MJN | 1999-07-30 | 275 |
| K972623 | LMI IRRIGATION CATHETER (IGR) | DXE | 1997-11-19 | 128 |
| K970657 | LMI THROMBECTOMY CATHETER | DXE | 1997-07-01 | 130 |
| K955126 | LMI BILIARY CATHETER | FGE | 1996-05-10 | 183 |
| K954760 | LMI ARTERIAL EMBOLECTOMY CATHETER | DXE | 1996-04-11 | 177 |
| K955125 | LMI OCCLUSION CATHETER | DXE | 1996-03-11 | 123 |
| K955499 | LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER | MJN | 1996-02-28 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Lucas Medical, 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.
- Lucas Grason-Stadler, Inc. (3 510(k)s)
- Lucas Lifecare (2 510(k)s)
- Lucas & Rhea Mfg. (1 510(k)s)
- Lucas Sensing Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lucas Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Lucas Medical, Inc.” (first 1996, latest 1999), 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 Lucas Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lucas Medical, Inc. is 130 days.
Which FDA product codes appear under Lucas Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXE (Catheter, Embolectomy, 4); MJN (Catheter, Intravascular Occluding, Temporary, 2); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Next steps
- See all 7 Lucas Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXE, Lucas Medical, 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.