# K212152: Prelude IDeal 9F Hydrophilic Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems
- Decided: Jan 7, 2022 after 182 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: 8 generations back to K954234 (1995). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173750: Prelude IDeal Hydrophilic Sheath Introducer, Merit Medical Systems, Inc. (2018) Summary page 4.

## Cited in the summary but kept off the family tree
- K171750: Citric Complete Dry Citric Acid (45X), Dimesol USA, LLC (2018). Our reading of the summary gave K171750, FDA’s number for Citric Complete Dry Citric Acid (45X) (Dimesol USA, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Prelude IDeal™ Hydrophilic Sheath Introducer”. Kept off the family tree. Summary page 11.

## Most influential descendants
- 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

## Indications for use
The 9F Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K212152
Methodology: https://510kreport.com/methodology