510(k) · Cleared
Recalled · 2009Tyshak Peripheral Balloon Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuMED, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 21, 1993 after a 305-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 1993
- Review
- 305 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK931009 Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc. · 1993
- Descendant · cites it directly · 2 of its ownK013601 Numed Mullins Pta CatheterNuMED, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK991977 Tyshak, Model 102 and Z-Med, Model 302NuMED, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK050857 Bib Pta Balloon CatheterNuMED, Inc. · 2005 · Recalled
- Descendant · cites it directly · 1 of its ownK040830 Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK160889 BIB Stent Placement CatheterNuMED, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K013601Numed Mullins Pta CatheterNuMED, Inc. · 2002 · cites it directly2descendants
- K991977Tyshak, Model 102 and Z-Med, Model 302NuMED, Inc. · 2000 · cites it directly2descendants
- K050857Bib Pta Balloon CatheterNuMED, Inc. · 2005 · cites it directly1descendant
- K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2004 · cites it directly1descendant
- K160889BIB Stent Placement CatheterNuMED, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931009 | Tyshak Peripheral Balloon Dilation Catheter | NuMED, Inc. | 1993 | — |
| +1 | K013601 | Numed Mullins Pta Catheter | NuMED, Inc. | 2002 | — |
| +1 | K991977 | Tyshak, Model 102 and Z-Med, Model 302 | NuMED, Inc. | 2000 | — |
| +1 | K050857 | Bib Pta Balloon Catheter | NuMED, Inc. | 2005 | 1 |
| +1 | K040830 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters | NuMED, Inc. | 2004 | — |
| +2 | K160889 | BIB Stent Placement Catheter | NuMED, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2009 | Not classified | Z-0509-2010 | Labeling design | The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013601 (NuMED, Inc., 2002) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K931009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931009: Tyshak Peripheral Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931009
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026