Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lumendi, LLC — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
180 daysmedian FDA review time
268 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023-02-10 | 268 | 0 |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021-10-22 | 133 | 0 |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021-04-21 | 30 | 0 |
| K183112 | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) | Lumendi, LLC | 2019-08-02 | 267 | 0 |
| K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018-10-30 | 46 | 0 |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | Lumendi, LLC | 2018-05-22 | 203 | 0 |
| K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | 2018-04-17 | 180 | 0 |
| K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2016-12-06 | 98 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda