# 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

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Nov 20, 2024 after 110 days
- Product code: QNQ (Low Dead Space Piston Syringe)
- 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 K904198 (1990). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232943: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe, Smiths Medical Asd, Inc. (2024) Summary page 5.

## Most influential descendants
- K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (2026), 0 descendants of its own
- K252814: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle;  Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (2026), 0 descendants of its own

## Indications for use
The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body. The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable needle is used to inject fluids into, or withdraw fluids from, the body. The Luer Lock Syringe (Low Dead Space) 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.

Source page: https://510kreport.com/device/K242291
Methodology: https://510kreport.com/methodology