# K021197: Sureone Insulin Syringe, 31 Gauge X 5/16

- Pathway: 510(k) (Special)
- Applicant: Hosuk Co., Ltd.
- Decided: Apr 26, 2002 after 10 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002921 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002921: Sureone Insulin Syringe, Hosuk Co., Ltd. (2000) Summary page 1.
- K002403: Novofine 31 Disposable Needle, Novo Norodisk Pharmaceuticals, Inc. (2000) Summary page 1.

## Recalls of this device
- Oct 27, 2009 · Not classified · Z-0573-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0576-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0570-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0571-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0574-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0575-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0569-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0572-2010: Needles are becoming dislodged from the barrels
- Aug 21, 2009 · Not classified · Z-2247-2009: Needles separate from the barrels of the syringes
- Aug 21, 2009 · Not classified · Z-2248-2009: Needles separate from the barrels of the syringes

## Indications for use
Insulin syringes are intended only for the injection of U-100 insulin.

Source page: https://510kreport.com/device/K021197
Methodology: https://510kreport.com/methodology