# K213429: AccuSert Needle Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Emed Technologies Corporation
- Decided: Oct 20, 2022 after 364 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 K010377 (2001). 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)
- K010377: Mimimed Sil-Serter Infusion Set Insertion System, Model 385, Minimed, Inc. (2001) Summary page 4.

## Indications for use
AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.

Source page: https://510kreport.com/device/K213429
Methodology: https://510kreport.com/methodology