# K002921: Sureone Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Hosuk Co., Ltd.
- Decided: Oct 18, 2000 after 29 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021197: Sureone Insulin Syringe, 31 Gauge X 5/16 (2002), 0 descendants of its own

## Recalls of this device
- Feb 24, 2003 · Not classified · Z-0003-04: The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
- Feb 24, 2003 · Not classified · Z-0004-04: The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
- Feb 24, 2003 · Not classified · Z-0005-04: The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .

Source page: https://510kreport.com/device/K002921
Methodology: https://510kreport.com/methodology