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 Sep 12, 1996 as substantially equivalent to K897106 (Boston Scientific Corp, 1990) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Sep 12, 1996
- Review
- 115 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K897106 (1990). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK897106 Medi-Tech Dilatation Catheters Ultra Thin IIBoston Scientific Corp · 1990
- This deviceK961980 Bipore Balloon Dilatation CatheterBipore, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK041293 Biopore Balloon Dilation CatheterBipore, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK973563 Bipore Balloon Dilatation CatheterBipore, Inc. · 1998
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K897106 | Medi-Tech Dilatation Catheters Ultra Thin II | Boston Scientific Corp | 1990 | — |
| 0 (this device) | K961980 | Bipore Balloon Dilatation Catheter | Bipore, Inc. | 1996 | — |
| +1 | K041293 | Biopore Balloon Dilation Catheter | Bipore, Inc. | 2004 | — |
| +1 | K973563 | Bipore Balloon Dilatation Catheter | Bipore, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K897106 | Medi-Tech Dilatation Catheters Ultra Thin IISummary page 1…e Generic Name: Balloon Dilatation Catheter Classification: Class II, Performance Standards Predicate Devices: Medi-tech Ultra-Thin Balloon Dilatation Catheter 510(k): K897106 and K920547 Description of Device: The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous tr… | 1990 |
| * | K920547 | Ultra-ThinSummary page 1…me: Balloon Dilatation Catheter Classification: Class II, Performance Standards Predicate Devices: Medi-tech Ultra-Thin Balloon Dilatation Catheter 510(k): K897106 and K920547 Description of Device: The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal a… | 1992 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K041293 (Bipore, Inc., 2004) has gone furthest, with 0 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?
The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
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/K961980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961980: 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/K961980
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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