# K990803: Medisystems Buttonhole Needle Sets

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Jan 6, 2000 after 302 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K823068 (1983). 2 ancestors in all.
6 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)
- K823068: Medisystems Fistula Needles, Medisystems Corp. (1983) Summary page 1.
- K951254: Safetyglide Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.

## Most influential descendants
- 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
- K130873: Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X 07MM; Vwing Vascular Needle Guide, 8MM X 07M (2013), 0 descendants of its own

## Recalls of this device
- Dec 20, 2012 · Class II · Z-0714-2013: A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".

## Indications for use
Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site or “buttonhole™ method of needle insertion.

Source page: https://510kreport.com/device/K990803
Methodology: https://510kreport.com/methodology