# K220881: Inoue Balloon a

- Pathway: 510(k) (Traditional)
- Applicant: Toray Industries, Inc.
- Decided: Dec 18, 2022 after 268 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN080015 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN080015: Nucleus-X PTV Catheter, NuMED, Inc. (2012). Our reading of the summary gave K082776, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080015, Nucleus-X PTV Catheter (NuMED, Inc.), granted Jun 11, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.
- DEN080015: Nucleus-X PTV Catheter, NuMED, Inc. (2012) Summary page 4.

## Indications for use
INOUE BALLOON A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.

Source page: https://510kreport.com/device/K220881
Methodology: https://510kreport.com/methodology