# K910734: Medisystems Hemodialysis Fistula Set

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Jun 20, 1991 after 119 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 20, 2012 · Class II · Z-0715-2013: Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
- Jan 31, 2012 · Not classified · Z-1126-2012: Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle

Source page: https://510kreport.com/device/K910734
Methodology: https://510kreport.com/methodology