# K252184: SOL-M Luer Lock Syringe with Exchangeable Needle Tray

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Aug 25, 2026 after 410 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: 9 generations back to K771205 (1977). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241821: Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle, Sol-Millennium Medical, Inc. (2024) Summary page 5.

## Indications for use
The Luer Lock Syringe with Exchangeable Needle Tray is used to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K252184
Methodology: https://510kreport.com/methodology