# K212499: BD Insulin Syringe (0.3mL)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 9, 2022 after 212 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190054: BD Insulin Syringe, Becton, Dickinson and Company (2019) Summary page 4.

## Indications for use
Becton Dickinson Insulin Syringes are intended for subcutaneous injection of U-100 insulins

Source page: https://510kreport.com/device/K212499
Methodology: https://510kreport.com/methodology