Lumen Biomedical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Lumen Biomedical, Inc.” (first 2006, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 95 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 |
|---|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | 2 | 2 |
| QEZ | Aspiration Thrombectomy Catheter | 2 | 2 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Lumen Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111987 | FIBERNET EMBOLIC PROTECTION DEVICE | NTE | 2011-08-17 | 35 |
| K082348 | FIBERNET EMBOLIC PROTECTION SYSTEM | NTE | 2008-11-18 | 95 |
| K080901 | LBI EMBOLECTOMY SYSTEM | QEW | 2008-10-02 | 185 |
| K071529 | XTRACT CATHETER SYSTEM | QEZ | 2007-08-10 | 66 |
| K053372 | LBI CATHETER SYSTEM | QEZ | 2006-06-30 | 207 |
Recalls
openFDA lists no recalls under a recalling firm named Lumen 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.
Device clinical trials
An industry sponsor named Lumen Biomedical, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00460187: EPIC US Pivotal Study (Completed, started 2007-03)
- NCT00453518: The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts (Completed, started 2007-03)
- NCT00349570: Xtract™ Aspiration Catheter Registry Study (Completed, started 2006-08)
- NCT00346515: EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting (Completed, started 2006-06)
- NCT00309803: EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting (Completed, started 2006-03)
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.
- Lumen Development and Manufacturing, Inc. (1 510(k)s)
- Lumen S.R.L. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lumen Biomedical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Lumen Biomedical, Inc.” (first 2006, latest 2011), 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 Lumen Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lumen Biomedical, Inc. is 95 days.
Which FDA product codes appear under Lumen Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are NTE (Temporary Carotid Catheter For Embolic Capture, 2); QEZ (Aspiration Thrombectomy Catheter, 2); QEW (Peripheral Mechanical Thrombectomy With Aspiration, 1).
Next steps
- See all 5 Lumen Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NTE, Lumen 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.