Lumendi, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Lumendi, LLC” (first 2016, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 156 days. Since 2017 the median was 180 days, against 112 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 1 | 98 |
| 2017 | 0 | — |
| 2018 | 3 | 180 |
| 2019 | 1 | 267 |
| 2020 | 0 | — |
| 2021 | 2 | 82 |
| 2022 | 0 | — |
| 2023 | 1 | 268 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lumendi, LLC took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
Review panels
Most recent Lumendi, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221452 | DiLumen C1, EZ1 and Tool Mount | FDF | 2023-02-10 | 268 |
| K211819 | DiLumen C2 and Tool Mount | FDF | 2021-10-22 | 133 |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | FDF | 2021-04-21 | 30 |
| K183112 | DiLumen Endolumenal Interventional Knife (DiLumen IK) | GEI | 2019-08-02 | 267 |
| K182540 | DiLumen Endolumenal Interventional Platform | FDF | 2018-10-30 | 46 |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | GEI | 2018-05-22 | 203 |
| K173317 | DiLumen C2; DiLumen Tool Mount | FDF | 2018-04-17 | 180 |
| K162428 | DiLumen Endolumenal Interventional Platform | FDF | 2016-12-06 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Lumendi, LLC.
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 Lumendi, LLC is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03551379: A Double Balloon Endoscopic Platform for ESD (Completed, started 2017-09-22)
- NCT03113578: Evaluation of the DiLumen Device During Colonoscopy (Completed, started 2017-04-26)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lumendi, LLC?
FDA lists 8 510(k) clearances under the applicant name “Lumendi, LLC” (first 2016, latest 2023), across 2 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 Lumendi, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lumendi, LLC is 156 days. Since 2017: 180 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lumendi, LLC?
The most frequent FDA product codes under this applicant name are FDF (Colonoscope And Accessories, Flexible/Rigid, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 8 Lumendi, LLC clearances with predicates and recalls
- Run predicate analysis for product code FDF, Lumendi, LLC'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.