De Novo · Granted
GrantedNucleus-X PTV Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuMED, Inc. · OZT Balloon Aortic Valvuloplasty
Granted on Jun 11, 2012 as a new device type through De Novo after a 1,265-day review. 6 later devices descend from it.
- Decided
- Jun 11, 2012
- Review
- 1,265 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
6 later devices descend from it, 4 citing it directly.
- This deviceDEN080015 Nucleus-X PTV CatheterNuMED, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK123111 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK132728 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK133607 V8 Transluminal Bav CatheterIntervalve, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK150343 V8 Transluminal BAV CatheterIntervalve, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK220881 Inoue Balloon aToray Industries, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123111V8 Transluminal Bav CatheterIntervalve, Inc. · 2013 · cites it directly4descendants
- K132728V8 Transluminal Bav CatheterIntervalve, Inc. · 2013 · cites it directly3descendants
- K133607V8 Transluminal Bav CatheterIntervalve, Inc. · 2014 · cites it directly2descendants
- K150343V8 Transluminal BAV CatheterIntervalve, Inc. · 2015 · 2 generations on1descendant
- K220881Inoue Balloon aToray Industries, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN080015 | Nucleus-X PTV Catheter | NuMED, Inc. | 2012 | — |
| +1 | K123111 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| +1 | K132728 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| +1 | K133607 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2014 | 1 |
| +2 | K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015 | — |
| +1 | K220881 | Inoue Balloon a | Toray Industries, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K123111 (Intervalve, Inc., 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OZT devicesOZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 | — |
https://510kreport.com/device/DEN080015 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN080015: Nucleus-X PTV Catheter.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN080015
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026