# K010377: Mimimed Sil-Serter Infusion Set Insertion System, Model 385

- Pathway: 510(k) (Traditional)
- Applicant: Minimed, Inc.
- Decided: Apr 5, 2001 after 56 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K061374: Intuition Infusion Sets (2006), 2 descendants of its own
- K242692: SteadiSet Infusion Set (2025), 1 descendant of its own
- K251854: SteadiSet infusion set (2025), 0 descendants of its own
- K213429: AccuSert Needle Inserter (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K010377
Methodology: https://510kreport.com/methodology