# K123475: Shoocin Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Lepu Medical Technology (Beijing) Co., Ltd.
- Decided: Feb 3, 2014 after 447 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: 6 generations back to K954234 (1995). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111606: Pinnacle Precision Access System, Terumo Medical Corp. (2011) Summary page 1.

## Most influential descendants
- K140768: Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant Introducer Kit, Type IV Brilliant (2014), 1 descendant of its own
- K172331: Type I, Type II, Type III, Type IV (2018), 0 descendants of its own
- K172099: Shoocin Introducer Kit (2017), 0 descendants of its own

## Indications for use
The ShoocinlM'iIntroducer Kits are intended for use to facilitate the introduction of guide wires. catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

Source page: https://510kreport.com/device/K123475
Methodology: https://510kreport.com/methodology