# K932074: Medisystems Apheresis Needle with Guard

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Feb 18, 1994 after 296 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.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071145: Nipro Safetouch Tulip Safety Fistula Needle (2007), 3 descendants of its own
- K073257: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector (2008), 2 descendants of its own
- K163025: DORA Disposable A.V. Fistula Needle Sets (2017), 1 descendant of its own
- K102994: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector (2010), 1 descendant of its own
- K213015: DORA Disposable A.V. Fistula Needle Sets (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K932074
Methodology: https://510kreport.com/methodology