# K151870: BD U-500 Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 8, 2016 after 365 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003) Summary page 4.

## Indications for use
The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.

Source page: https://510kreport.com/device/K151870
Methodology: https://510kreport.com/methodology