510(k) · Cleared
ClearedNC PTA 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 Sep 16, 2026 as substantially equivalent to K181323 (C.R. Bard, Inc., 2018) after a 261-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Sep 16, 2026
- Review
- 261 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933483 (1993). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 6 generations backK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- 5 generations backK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- 4 generations backK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- 3 generations backK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- 2 generations backK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- 1 generation backK181323 Atlas Gold PTA Dilatation CatheterC.R. Bard, Inc. · 2018
- This deviceK254212 NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| −6 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| −5 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| −4 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| −3 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| −2 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| −1 | K181323 | Atlas Gold PTA Dilatation Catheter | C.R. Bard, Inc. | 2018 | — |
| 0 (this device) | K254212 | NC PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K181323 | Atlas Gold PTA Dilatation CatheterSummary page 4…ansluminal Name: Regulation Number: 21 CFR 870.1250 Product Code: LIT Regulatory Class: Class II Predicate Device: Atlas® Gold PTA Dilatation Catheter (K181323) Reference device: MAXI LD PTA Dilatation Catheter (K96300) Device Description: The NC PTA Balloon Dilatation Catheter is… | 2018 |
| † | K096300 | MAXI LD PTA Dilatation Catheter |
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 33 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K181323.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 NC PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native 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/K254212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254212: NC PTA Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254212
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026