510(k) · Cleared
ClearedInoue Balloon a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toray Industries, Inc. · OZT Balloon Aortic Valvuloplasty
Cleared on Dec 18, 2022 as substantially equivalent to DEN080015 (NuMED, Inc., 2012) and 1 other predicate after a 268-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Dec 18, 2022
- Review
- 268 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN080015 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backDEN080015 Nucleus-X PTV CatheterNuMED, Inc. · 2012
- This deviceK220881 Inoue Balloon aToray Industries, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN080015 | Nucleus-X PTV Catheter | NuMED, Inc. | 2012 | — |
| 0 (this device) | K220881 | Inoue Balloon a | Toray Industries, Inc. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OZT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OZT device
- #1 K253855 KardiaPSI Balloon Catheterscore 11.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN080015 | Nucleus-X PTV Catheter 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. | 2012 |
| * | DEN080015 | Nucleus-X PTV CatheterSummary page 4…heter, Balloon Aortic Valvuloplasty (21 CFR 870.1255) Regulatory Class: II Product Code: OZT III. PREDICATE DEVICE NuMED NuCLEUS and NuCLEUS-X BAV Catheters, K082776/DEN080015 5A-1 IV. DEVICE DESCRIPTION INOUE BALLOONTM A is intended for… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN080015.
How does its category compare?
All OZT devicesOZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OZT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZT
115in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZT
No recall names OZT since 2007.
Adverse event reports per year · OZT
34in 2025
MAUDE reports naming product code OZT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 3 | 80 | 0 | 29 |
| 2014 | 4 | 79 | 0 | 17 |
| 2015 | 4 | 115 | 0 | 16 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 38 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 1 | — | 0 | 33 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 1 | — | 0 | 38 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
INOUE BALLOON A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220881: Inoue Balloon a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220881
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026