# K160860: MiniMed Quick-serter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Sep 22, 2016 after 177 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 K992300 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992300: Quick-Serter, Model 395, Medtronic Minimed (1999) Summary page 4.

## Indications for use
The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.

Source page: https://510kreport.com/device/K160860
Methodology: https://510kreport.com/methodology