# K992300: Quick-Serter, Model 395

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Jul 29, 1999 after 21 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.
17 later devices descend from it; 3 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MiniMed Sof-serter™ infusion set insertion system: named in the summary without a submission number

## Most influential descendants
- K032854: Unomedical Monica Infusion Set (2003), 14 descendants of its own
- K173879: MiniMed Mio Advance infusion set (2018), 3 descendants of its own
- K061374: Intuition Infusion Sets (2006), 2 descendants of its own
- K243841: Sparta Infusion Set for Insulin (2025), 1 descendant of its own
- K242692: SteadiSet Infusion Set (2025), 1 descendant of its own

## Indications for use
The Quick-serter infusion set insertion system (Quick-serter), model 395, is indicated for use as an aid for insertion of the Maersk Medical A/S Contour infusion sets.

Source page: https://510kreport.com/device/K992300
Methodology: https://510kreport.com/methodology