# K200242: StaClear Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Tribofilm Research, Inc.
- Decided: Jul 27, 2020 after 178 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: 5 generations back to K931367 (1993). 21 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163161: Sterile Single-use Syringe with Needle, Jiangxi Hongda Medical Equipment Group, Ltd. (2017) Summary page 4.

## Most influential descendants
- K243936: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (2025), 1 descendant of its own
- K251849: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (2025), 0 descendants of its own
- K243027: Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) (2025), 0 descendants of its own
- K243149: Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (2024), 0 descendants of its own
- K230372: VitreJect Syringe (2023), 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/K200242
Methodology: https://510kreport.com/methodology