# K260208: Ultra-Fine™ SAFETY Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: embecta Medical II, LLC
- Decided: Jul 13, 2026 after 171 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 5.

## Indications for use
Ultra-Fine SAFETY Insulin Syringes are intended to be used for subcutaneous administration of insulin for the treatment of diabetes mellitus at a concentration of 100U/mL (U-100), while reducing the occurrence of accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Source page: https://510kreport.com/device/K260208
Methodology: https://510kreport.com/methodology