# K032848: Medsafe System Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Medsolve Technologies, LLC
- Decided: Apr 12, 2004 after 213 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 K872233 (1987). 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)
- K872233: Inject-Ease, Palco Laboratories, Inc. (1987) Summary page 3.

## Indications for use
Single-use non-sterile device intended to aid in the insertion of a commercially available syringe. The Safety feature prevents needle reuse.

Source page: https://510kreport.com/device/K032848
Methodology: https://510kreport.com/methodology