# Lumendi, LLC

- Location (FDA's records): Westport, CT
- FDA decisions: 8 (2016–2023): 8 510(k) clearances
- Product codes: FDF (6), GEI (2)
- 510(k) review time since 2016: median 157 days, against 96 for FDA's reviews in the same codes and years (1 of 8 faster)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cambridge Endoscopic Devices: 1 (https://510kreport.com/company/cambridge-endoscopic-devices)
- Fujinon, Inc.: 1 (https://510kreport.com/company/fujinon)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Bpendo, LLC: 1 (https://510kreport.com/company/bpendo)
- Aspero Medical, Inc.: 1 (https://510kreport.com/company/aspero-medical)

## Its most-cited devices
- K162428: DiLumen Endolumenal Interventional Platform (2016), cited by 2
- K211819: DiLumen C2 and Tool Mount (2021), cited by 1
- K173405: DiLumen Endolumenal Interventional Scissors (DiLumen Is) (2018), cited by 1
- K221452: DiLumen C1, EZ1 and Tool Mount (2023), cited by 1
- K182540: DiLumen Endolumenal Interventional Platform (2018), cited by 1
- K173317: DiLumen C2; DiLumen Tool Mount (2018), cited by 1

## Recent decisions
- K221452: DiLumen C1, EZ1 and Tool Mount (Feb 10, 2023)
- K211819: DiLumen C2 and Tool Mount (Oct 22, 2021)
- K210851: DiLumen Endolumenal Interventional Platform (DiLumen) (Apr 21, 2021)
- K183112: DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) (Aug 2, 2019)
- K182540: DiLumen Endolumenal Interventional Platform (Oct 30, 2018)
- K173405: DiLumen Endolumenal Interventional Scissors (DiLumen Is) (May 22, 2018)
- K173317: DiLumen C2; DiLumen Tool Mount (Apr 17, 2018)
- K162428: DiLumen Endolumenal Interventional Platform (Dec 6, 2016)

Source page: https://510kreport.com/company/lumendi