# K970479: Minimed Sof-Serter Infusion Set Insertion System, Model 300

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Mar 31, 1997 after 52 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945660 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945660: Autoject 2, Owen Mumford USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K063146: Accu-Chek Linkassist (2006), 0 descendants of its own

## Indications for use
The MiniMed Sof-serter infusion set insertion system is intended to help make insertion of a Sof-set or Sof-set QR infusion set simpler and with minimal discomfort. Use of the device may improve the user’s consistency of infusion set insertion.

Source page: https://510kreport.com/device/K970479
Methodology: https://510kreport.com/methodology