# K153698: LumenR Tissue Retractor System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenr, LLC
- Decided: Apr 19, 2016 after 118 days
- Product code: ODB (Endoscopic Contamination Prevention Sheath)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040836 (2004). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080550: Megachannel Endoscopic Overtube, Model OT22, Minos Medical (2008) Summary page 4.

## Most influential descendants
- K173400: ORISE Tissue Retractor System (2018), 2 descendants of its own
- K182540: DiLumen Endolumenal Interventional Platform (2018), 1 descendant of its own
- K210851: DiLumen Endolumenal Interventional Platform (DiLumen) (2021), 0 descendants of its own

## Indications for use
The LumenR Tissue Retractor System is indicated for use in conjunction with an endoscope for tissue or foreign body manipulation and/or where multiple removal and reinsertions of the endoscope are required.

Source page: https://510kreport.com/device/K153698
Methodology: https://510kreport.com/methodology