510(k) · Cleared
ClearedValvuloplasty Balloon Catheter (ValvuloPro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan TT Medical, Inc. · OZT Balloon Aortic Valvuloplasty
Cleared on Mar 20, 2026 as substantially equivalent to K240967 (Dongguan TT Medical, Inc., 2024) after a 37-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Mar 20, 2026
- Review
- 37 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K240967 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK240967 ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. · 2024
- This deviceK260437 Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2024 | — |
| 0 (this device) | K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | 2026 | — |
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? (1)
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 |
|---|---|---|---|
| * | K240967 | ValvuloPro Valvuloplasty Balloon CatheterSummary page 5…ber: K260437 3. Predicate Device Information The subject device is compared to the predicate device, ValvuloPro Valvuloplasty Balloon Catheter (K240967, cleared July 31, 2024), to demonstrate substantial equivalence. 4. Device Description Summary The ValvuloPro Valvuloplasty B… | 2024 |
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.
How does its category compare?
All OZT devicesOZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The ValvuloPro Valvuloplasty Balloon Catheter is indicated for balloon aortic vavuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260437: Valvuloplasty Balloon Catheter (ValvuloPro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260437
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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