# K222744: Sol-M Luer Lock Syringe

- Pathway: 510(k) (Special)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Oct 11, 2022 after 29 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: 4 generations back to K042102 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101359: Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML), Inviro Medical Devices, Inc. (2010) Summary page 4.

## Indications for use
The Sol-Millennium Medical Inc. Luer Lock Syringe is intended for aspiration and injection of medications and fluids into the body.

Source page: https://510kreport.com/device/K222744
Methodology: https://510kreport.com/methodology