# K152435: PassAssist LED Light Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Nov 20, 2015 after 85 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921244 (1992). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141916: Pathassist Led Light Fiber, Entellus Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K230258: BB 8 Sinus Dilation Kit (2023), 0 descendants of its own
- K201398: SINUSPRIME Dilation System (2020), 0 descendants of its own

## Indications for use
To locate, illuminate within, and transilluminate across nasal and sinus structures.

Source page: https://510kreport.com/device/K152435
Methodology: https://510kreport.com/methodology