# K980580: Becton Dickinson Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jun 25, 1998 after 128 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
No predicates in its family tree.
141 later devices descend from it; 9 cite it directly.
2 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Single Use Hypodermic and Insulin Syringes: named in the summary without a submission number

## Most influential descendants
- K024052: Merit Medical 1-ML Syringe (2003), 111 descendants of its own
- K070936: Welmed Hypodermic Syringe (2007), 88 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own

## Indications for use
The general use syringes are intended for the aspiration and injection of fluids. Insulin syringes are intended for the injection of insulin.

Source page: https://510kreport.com/device/K980580
Methodology: https://510kreport.com/methodology