# K152803: Sungshim Sterile Single Use Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sung Shim Medicare Co., Ltd.
- Decided: Jul 12, 2016 after 288 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 K941657 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070917: Feel-Ject Insulin Syringe, Feel Tech (2007) Summary page 4.

## Indications for use
SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)

Source page: https://510kreport.com/device/K152803
Methodology: https://510kreport.com/methodology