# K133311: Endoled

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jul 30, 2014 after 275 days
- Product code: NTN (Led Light Source)
- 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: 8 generations back to K921244 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091829: PLS Portable Light Source, Optim, Inc. (2009) Summary page 1.

## Indications for use
The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.

Source page: https://510kreport.com/device/K133311
Methodology: https://510kreport.com/methodology