# K140543: Preludeease Hydrophilic Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 16, 2014 after 226 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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: 5 generations back to K954234 (1995). 14 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070159: Prelude Sheath Introducer, Merit Medical Systems, Inc. (2007) Summary page 4.
- K102008: Glidesheath, Terumo Medical Corp. (2010) Summary page 4.

## Most influential descendants
- K150257: PreludeEASE Hydrophilic Sheath Introducer (2015), 5 descendants of its own
- K173750: Prelude IDeal Hydrophilic Sheath Introducer (2018), 4 descendants of its own
- K212152: Prelude IDeal 9F Hydrophilic Sheath Introducer (2022), 2 descendants of its own
- K232260: Thinline Sheath Introducer (2023), 1 descendant of its own
- K261529: Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) (2026), 0 descendants of its own

## Recalls of this device
- Dec 1, 2016 · Class II · Z-0949-2017: Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of a

## Indications for use
The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.

Source page: https://510kreport.com/device/K140543
Methodology: https://510kreport.com/methodology