# K172331: Type I, Type II, Type III, Type IV

- Pathway: 510(k) (Traditional)
- Applicant: Lepu Medical Technology (Beijing) Co., Ltd.
- Decided: Mar 2, 2018 after 212 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). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140768: Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant Introducer Kit, Type IV Brilliant, Lepu Medical Technology (Bejing) Co., Ltd. (2014) Summary page 4.

## Indications for use
The Brilliant Introducer 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/K172331
Methodology: https://510kreport.com/methodology