# K243936: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

- Pathway: 510(k) (Special)
- Applicant: Staclear, Inc.
- Decided: Apr 3, 2025 after 104 days
- Product code: QLY (Ophthalmic 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: 6 generations back to K931367 (1993). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200242: StaClear Syringe, Tribofilm Research, Inc. (2020) Summary page 5.

## Most influential descendants
- K251849: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (2025), 0 descendants of its own

## Indications for use
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.

Source page: https://510kreport.com/device/K243936
Methodology: https://510kreport.com/methodology