# K030728: Fyrelink VL

- Pathway: 510(k) (Traditional)
- Applicant: Mpacs, LLC
- Decided: May 23, 2003 after 77 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K000380 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011944: Dyonics Vision 635 Digital Capture System, Model 7209088, Smith & Nephew, Inc. (2001)

## Indications for use
This device is intended for use when there is a need to convert endoscopic and microscopic surgical video to a digital video format for subsequent review and archiving. This device will also transfer the digital video over digital networks and/or digital communication lines.

Source page: https://510kreport.com/device/K030728
Methodology: https://510kreport.com/methodology