510(k) · Cleared
ClearedPTA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kossel Medtech (Suzhou) Co., Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 14, 2022 as substantially equivalent to K133843 (Cordis Corporation, 2014) after a 226-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Dec 14, 2022
- Review
- 226 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001134 (2000). 28 ancestors in all, the oldest K971010 (1997). No later device cites it as a predicate yet.
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations between
- 3 generations backK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- 2 generations backK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
- 1 generation backK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- This deviceK221245 PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 8 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 7 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 6 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 5 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 4 generations backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- 3 generations backK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- 2 generations backK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
- 1 generation backK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- This deviceK221245 PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −8 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −7 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −6 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −5 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| −4 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| −3 | K112797 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corp. | 2012 | — |
| −2 | K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corporation | 2012 | 2 |
| −1 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 1 |
| 0 (this device) | K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation CatheterSummary page 4…LIT Predicate Device: Predicate Device: SABER .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K133843, cleared May 19, 2014) Device Description: The 0.0180″ PTA balloon dilatation catheter is mainly composed of tip tube,… | 2014 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K133843.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221245: PTA 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/K221245
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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