510(k) · Cleared
ClearedPaladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contego Medical, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jun 9, 2022 as substantially equivalent to K181128 (Contego Medical, LLC, 2018) after a 31-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Jun 9, 2022
- Review
- 31 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001134 (2000). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 7 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 6 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 5 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 4 generations backK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008
- 3 generations backK093720 Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL…Boston Scientific Corp · 2009
- 2 generations backK141150 Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014
- 1 generation backK181128 Paladin Carotid Post-dilation Balloon System with Integrated Embolic…Contego Medical, LLC · 2018
- This deviceK221339 Paladin Carotid Post-Dilation Balloon System with Integrated Embolic…Contego Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −7 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −6 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −5 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −4 | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters | Boston Scientific Corp | 2008 | — |
| −3 | K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL… | Boston Scientific Corp | 2009 | — |
| −2 | K141150 | Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2014 | — |
| −1 | K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic… | Contego Medical, LLC | 2018 | — |
| 0 (this device) | K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Summary page 4…c Capture Product Code: LIT, NTE Predicate Device: Carotid Post-Dilation Balloon System with Integrated Embolic Protection (K181128) K221339… | 2018 |
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 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
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 Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221339: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221339
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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