Lumend, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Lumend, Inc.” (first 2001, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 8 | 8 |
| PDU | Catheter For Crossing Total Occlusions | 3 | 3 |
Review panels
- Cardiovascular (11)
Most recent Lumend, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043534 | MODIFICATION TO OUTBACK CATHETER | DQY | 2005-01-21 | 30 |
| K040771 | MODIFICATION TO OUTBACK CATHETER | DQY | 2004-04-23 | 29 |
| K033535 | LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES | PDU | 2004-01-07 | 58 |
| K032298 | MODIFICATION TO OUTBACK CATHETER | DQY | 2003-08-26 | 32 |
| K031005 | LUMEND FRONTRUNNER GW CTO CATHETER | PDU | 2003-06-18 | 79 |
| K023114 | LUMEND FRONTRUNNER CTO CATHETER | PDU | 2003-01-23 | 126 |
| K023223 | MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER | DQY | 2002-10-24 | 27 |
| K013284 | LUMEND FRONTRUNNER CTO CORONARY CATHETER | DQY | 2002-02-11 | 132 |
| K011562 | LUMEND PERCUTANEOUS CATHETER | DQY | 2002-01-16 | 240 |
| K014117 | MODIFICATION TO OUTBACK CATHETER | DQY | 2002-01-11 | 28 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-05-18.
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 Lumend, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Lumend, Inc.” (first 2001, latest 2005), across 2 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 Lumend, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lumend, Inc. is 58 days.
Which FDA product codes appear under Lumend, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 8); PDU (Catheter For Crossing Total Occlusions, 3).
Next steps
- See all 11 Lumend, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Lumend, 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.