510(k) · Cleared
ClearedBard Tru-Trac Peripheral Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 9, 1996 after a 64-day review. The FDA summary names its predicate without a number. 2 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Apr 9, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK960517 Bard Tru-Trac Peripheral Balloon Dilatation CatheterC.R. Bard, Inc. · 1996
- Descendant · cites it directly · 12 of its ownK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
- Descendant · 2 generations on · 10 of its ownK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- Descendant · 3 generations on · 6 of its ownK040014 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and…Portex, Ltd. · 2004
- Descendant · 3 generations on · 5 of its ownK041348 Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial…Smiths Medical · 2004 · Recalled
- Descendant · 4 generations on · 2 of its ownK133597 Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue…Cook, Inc. · 2014 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K983830Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999 · cites it directly12descendants
- K022212Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003 · 2 generations on10descendants
- K040014Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Portex, Ltd. · 2004 · 3 generations on6descendants
- K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical · 2004 · 3 generations on5descendants
- K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc. · 2014 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960517 | Bard Tru-Trac Peripheral Balloon Dilatation Catheter | C.R. Bard, Inc. | 1996 | — |
| +1 | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | Mallinckroot, Inc. | 1999 | — |
| +2 | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| +3 | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft… | Portex, Ltd. | 2004 | — |
| +3 | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators… | Smiths Medical | 2004 | 1 |
| +4 | K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino… | Cook, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 1 |
| 2019 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | Medi-Tech® Ultra-Thin™ Balloon Dilatation Catheter Named without a submission number |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | 1999 | 12 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K983830 (Mallinckroot, Inc., 1999) has gone furthest, with 12 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Any use of this product for procedures other than those indicated is not recommended.
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/K960517 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960517: Bard Tru-Trac Peripheral Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960517
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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