510(k) · Cleared
ClearedUltraverse 014 and 018 PTA Balloon Dilatation Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Oct 3, 2019 as substantially equivalent to K121856 (C.R. Bard, Inc., 2012) after a 38-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Oct 3, 2019
- Review
- 38 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K012913 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK012913 Bard Utaverse Small Vessel Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2001
- 2 generations backK093965 Ultraverse 014 and 018 Balloon Dilatation CathetersC.R. Bard, Inc. · 2010
- 1 generation backK121856 Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionC.R. Bard, Inc. · 2012
- This deviceK192318 Ultraverse 014 and 018 PTA Balloon Dilatation CathetersBard Peripheral Vascular, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK223177 Highlander™ 014 PTA Balloon Dilatation CatheterC.R. Bard, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223177Highlander™ 014 PTA Balloon Dilatation CatheterC.R. Bard, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012913 | Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2001 | — |
| −2 | K093965 | Ultraverse 014 and 018 Balloon Dilatation Catheters | C.R. Bard, Inc. | 2010 | — |
| −1 | K121856 | Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension | C.R. Bard, Inc. | 2012 | — |
| 0 (this device) | K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | Bard Peripheral Vascular, Inc. | 2019 | — |
| +1 | K223177 | Highlander™ 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · 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 |
|---|---|---|---|
| * | K121856 | Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionSummary page 4…Cardiovascular Regulation Number: 21 CFR 870.1250 Predicate Device: Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters (K121856; cleared July 11, 2012) Reference Device: Ultraverse® 035 PTA Balloon Dilatation Catheters (K142261; cleared… | 2012 |
| † | K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223177 | Highlander™ 014 PTA Balloon Dilatation Catheter | 2023 | 0 |
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 18 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K223177 (C.R. Bard, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121856.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
Ultraverse® 014 and Ultraverse® 018 PTA Balloon Dilatation Catheters are recommended for use in percutaneous trasluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. These catheters are not for use in coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192318: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192318
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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