# K241821: Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Sep 20, 2024 after 88 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: 8 generations back to K771205 (1977). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221247: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle, Jiangsu Kangbao Medical Equipment Co., Ltd. (2022) Summary page 6.

## Most influential descendants
- K252184: SOL-M Luer Lock Syringe with Exchangeable Needle Tray (2026), 0 descendants of its own
- K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (2026), 0 descendants of its own

## Indications for use
The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from, the body. The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.

Source page: https://510kreport.com/device/K241821
Methodology: https://510kreport.com/methodology