# K091167: Shina Insulin Syringe-Including Accu-Sure Insulin Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Shina Corp.
- Decided: Aug 6, 2009 after 106 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: 2 generations back to K941657 (1994). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 1.
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003) Summary page 1.

## Most influential descendants
- K152879: Sure-Fine Insulin Syringes (2016), 3 descendants of its own
- K191531: Sure-Fine Insulin Syringes (2019), 2 descendants of its own
- K210848: Sure-Fine Insulin Syringes (2022), 1 descendant of its own
- K250510: Sure-Fine Insulin Syringes (2025), 0 descendants of its own

## Indications for use
This device is a hypodermic insulin syringe for subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K091167
Methodology: https://510kreport.com/methodology