510(k) · Cleared
ClearedBipore Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bipore, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 1, 1998 as substantially equivalent to K961980 (Bipore, Inc., 1996) after a 194-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 1, 1998
- Review
- 194 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K897106 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K897106 | Medi-Tech Dilatation Catheters Ultra Thin II | Boston Scientific Corp | 1990 | — |
| −1 | K961980 | Bipore Balloon Dilatation Catheter | Bipore, Inc. | 1996 | — |
| 0 (this device) | K973563 | Bipore Balloon Dilatation Catheter | Bipore, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K961980 | Bipore Balloon Dilatation CatheterSummary page 1…Parkway Northvale, NJ 07647 Tel (201)767-1993 Fax (201) 767-0435 Balloon Dilatation Catheter Class I, Performance Standards Bipore Balloon Dilatation Catheter 510(k) K961980 The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutancous transluminal angioplasty in periphera… | 1996 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K961980.
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?
The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Bipore Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Bipore Dilatation Catheter for post-deployment stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*.
All stents must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.
Testing included: Rated Burst Pressure within the Stent
Balloon Fatigue within the Stent
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/K973563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973563: Bipore Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973563
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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