# K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Jun 18, 2026 after 267 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). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 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.
- K242291: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle, Sol-Millennium Medical, Inc. (2024) Summary page 5.
- K012736: Monoject Safety Needle, Tyco Healthcare (2001) Summary page 5.

## Indications for use
The Sol-Glide™ Safety Needle is used in conjunction with a standard syringe. The Sol-Glide™ Safety Needle with Syringe is used to inject fluids into, or withdraw fluids from the body. The safety mechanism encapsulates the needle after use. In the activated position, the protective shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

Source page: https://510kreport.com/device/K253110
Methodology: https://510kreport.com/methodology