# K163161: Sterile Single-use Syringe with Needle

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Hongda Medical Equipment Group, Ltd.
- Decided: Mar 20, 2017 after 130 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: 4 generations back to K931367 (1993). 20 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072739: Jierui Syringes and Needles, Shandong Weigao Group Medical Polymer Co., Ltd. (2008) Summary page 5.

## Most influential descendants
- K200242: StaClear Syringe (2020), 5 descendants of its own
- 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

## Indications for use
Sterile Single-use Syringe with Needle is intended to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K163161
Methodology: https://510kreport.com/methodology