# K202231: JADE

- Pathway: 510(k) (Traditional)
- Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decided: Dec 10, 2020 after 125 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K001134 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173894: Jade PTA Balloon Dilatation Catheter, Orbusneich Medical Trading, Inc. (2018)

## Most influential descendants
- K241025: JADE PLUS PTA Balloon Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K202231
Methodology: https://510kreport.com/methodology