510(k) · Cleared
ClearedTrue BA V Balloon Valvuloplasty Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · OZT Balloon Aortic Valvuloplasty
Cleared on Sep 18, 2014 as substantially equivalent to K133569 (Bard Peripheral Vascular, Inc., 2013) and 1 other predicate after a 58-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Sep 18, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K933483 (1993). 15 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 6 generations backK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- 5 generations backK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- 4 generations backK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- 3 generations backK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- 2 generations backK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- 1 generation backK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
- This deviceK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK251915 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc. · 2022 · cites it directly2descendants
- K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024 · 2 generations on1descendant
- K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| −6 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| −5 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| −4 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| −3 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| −2 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| −1 | K131002 | Vida PTV Dilataton Catheter | C.R. Bard, Inc. | 2013 | — |
| 0 (this device) | K141985 | True BA V Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2014 | — |
| +1 | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida… | C.R. Bard, Inc. | 2022 | — |
| +2 | K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2024 | — |
| +3 | K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | K133569 | True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X…Summary page 1…1 CFR 870.1250, Product Code OZT) Classification: Class Il Classification Panel: Cardiovascular Predicate Devices: e True Dilatation™ Balloon Valvuloplasty Catheter (K133569; cleared December 20, 2013) ¢ Vida™ PTV Dilatation Catheter (K131002, cleared July 2, 2013) TRADE SECRET/CONFIDENTIAL INFORMATIO… | 2013 |
| * | K131002 | Vida PTV Dilataton CatheterSummary page 1…cation Panel: Cardiovascular Predicate Devices: e True Dilatation™ Balloon Valvuloplasty Catheter (K133569; cleared December 20, 2013) ¢ Vida™ PTV Dilatation Catheter (K131002, cleared July 2, 2013) TRADE SECRET/CONFIDENTIAL INFORMATION [B&[RED Bard Peripheral Vascular, Inc. Nolify CR Bard Betore Releas… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV… | 2022 | 2 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K212588 (C.R. Bard, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K133569.
How does its category compare?
All OZT devicesOZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K141985: True BA V Balloon Valvuloplasty Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K141985
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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