# K252295: Ryurei

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corporation
- Decided: Mar 27, 2026 after 247 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K042537 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180921: Sapphire II PRO Balloon Dilatation Catheter, Orbusneich Medical Trading, Inc. (2018) Summary page 6.

## Indications for use
Ryurei (1.5 mm) is indicated for: • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. • Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. Ryurei (2.0–4.0 mm) is indicated for: • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. • Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. • Balloon post-deployment expansion of balloon expandable stents (bare metal and drug-eluting).

Source page: https://510kreport.com/device/K252295
Methodology: https://510kreport.com/methodology