# K024112: BD Insulin Syringe

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 9, 2003 after 27 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941657 (1994). 2 ancestors in all.
37 later devices descend from it; 11 cite it directly.
0 of 40 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 1.
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 1.

## Most influential descendants
- K040036: Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905 (2004), 10 descendants of its own
- K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe (2005), 8 descendants of its own
- K062702: Ulticare Disposable Syringes and Needles (2006), 6 descendants of its own
- K152808: U&U Insulin Syringe with/without Safety Retractable Device (2016), 5 descendants of its own
- K070917: Feel-Ject Insulin Syringe (2007), 5 descendants of its own

## Recalls of this device
- May 25, 2017 · Class II · Z-0183-2018: Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine 
- Jun 15, 2011 · Not classified · Z-0174-2012: Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
- Jun 21, 2007 · Not classified · Z-1226-2007: Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

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

Source page: https://510kreport.com/device/K024112
Methodology: https://510kreport.com/methodology