# K170386: BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle

- Pathway: 510(k) (Special)
- Applicant: Becton Dickinson & Company
- Decided: Apr 12, 2017 after 63 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.
3 later devices descend from it; 1 cites it directly.
0 of 7 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 4.
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 4.
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003) Summary page 4.

## Most influential descendants
- K190054: BD Insulin Syringe (2019), 2 descendants of its own
- K260208: Ultra-Fine™ SAFETY Insulin Syringe (2026), 0 descendants of its own
- K212499: BD Insulin Syringe (0.3mL) (2022), 0 descendants of its own

## Indications for use
Becton Dickinson insulin syringes are intended for subcutaneous injection of U100 insulin.

Source page: https://510kreport.com/device/K170386
Methodology: https://510kreport.com/methodology