# K173601: Merit Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 31, 2018 after 71 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980580 (1998). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070936: Welmed Hypodermic Syringe, Welmed, Inc. (2007) Summary page 4.

## Most influential descendants
- K191254: EndoClot (2020), 1 descendant of its own
- K260997: Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01) (2026), 0 descendants of its own
- K250853: Merit Syringe (2025), 0 descendants of its own
- K203738: Qitexio (2022), 0 descendants of its own

## Recalls of this device
- Feb 2, 2018 · Class II · Z-2742-2018: Supplier manufacturing defect with the syringe plunger tip.

## Indications for use
The Merit Syringe is used to inject fluids into, and withdraw fluids from, the body.

Source page: https://510kreport.com/device/K173601
Methodology: https://510kreport.com/methodology