# K140513: Merit Safety Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 9, 2014 after 131 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801941 (1980). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050023: Secureloc; Advancintroducer, Specialized Health Products, Inc. (2005) Summary page 1.

## Indications for use
The Merit Safety Introducer Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It also incorporates a safety mechanism to minimize needlestick injuries.

Source page: https://510kreport.com/device/K140513
Methodology: https://510kreport.com/methodology