# K024052: Merit Medical 1-ML Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 21, 2003 after 77 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: 1 generation back to K980580 (1998). 1 ancestor in all.
111 later devices descend from it; 3 cite it directly.
2 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980580: Becton Dickinson Syringes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.

## Most influential descendants
- 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
- K070856: Icu Medical Single-Use Syringe (2007), 18 descendants of its own

## Indications for use
Merit Medical I-mL Syringes are used to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K024052
Methodology: https://510kreport.com/methodology