# K823068: Medisystems Fistula Needles

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Jan 26, 1983 after 99 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices 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.

## Most influential descendants
- K990803: Medisystems Buttonhole Needle Sets (2000), 6 descendants of its own
- K082882: A.V. Fistula Blunt Needle Set (2009), 2 descendants of its own
- K093637: JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300 (2010), 1 descendant of its own
- K151017: JMS Harmony A.V. Fistula Needle Set (2015), 0 descendants of its own
- K134019: Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector, Medisystems Onesite Dual Lumen Butto (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K823068
Methodology: https://510kreport.com/methodology