# K190054: BD Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Oct 21, 2019 after 283 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941657 (1994). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- 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, Becton Dickinson & Company (2017) Summary page 4.

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

## Recalls of this device
- Feb 1, 2023 · Class II · Z-1238-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Feb 1, 2023 · Class II · Z-1240-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Feb 1, 2023 · Class II · Z-1244-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Feb 1, 2023 · Class II · Z-1243-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Feb 1, 2023 · Class II · Z-1237-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Feb 1, 2023 · Class II · Z-1242-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Feb 1, 2023 · Class II · Z-1241-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Feb 1, 2023 · Class II · Z-1239-2023: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

## Indications for use
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins

Source page: https://510kreport.com/device/K190054
Methodology: https://510kreport.com/methodology