# K220713: Sol-Guard Auto-disable Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: May 4, 2023 after 419 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931367 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153537: Sol-M  Insulin Syringe, Sol-M TB Syringe, Sol-Millennium Medical, Inc. (2016) Summary page 4.

## Indications for use
The Sol-Guard Auto-Disable Syringe is intended for aspiration and injection of fluids into the body. In addition, the Sol-Guard Auto-Disable Syringe is designed to prevent syringe and needle reuse.

Source page: https://510kreport.com/device/K220713
Methodology: https://510kreport.com/methodology