# K992653: Shelly Protected AV Fistula Needle

- Pathway: 510(k) (Traditional)
- Applicant: Diasol, Inc.
- Decided: Oct 27, 1999 after 82 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Fistula needle is part of the hemodialysis system. It connects to machine and provides access to the patient’s blood. It is also used in plasmapheresis for the same purpose.

Source page: https://510kreport.com/device/K992653
Methodology: https://510kreport.com/methodology