510(k) · Cleared
ClearedChocolate PTA Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 15, 2021 as substantially equivalent to K130414 (Trireme Medical, Inc., 2013) after a 28-day review. Its family tree reaches back 12 generations to 2000.
- Decided
- Dec 15, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001134 (2000). 43 ancestors in all, the oldest K945904 (1995). No later device cites it as a predicate yet.
- Root · 12 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 8 generations between
- 3 generations backK121402 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- 2 generations backK122070 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- 1 generation backK130414 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2013
- This deviceK213631 Chocolate PTA Balloon CatheterMedtronic, Inc. · 2021
Show all 12 generations
- Root · 12 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 11 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 10 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 9 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 8 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 7 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- 6 generations backK101062 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
- 5 generations backK103534 Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018…Trireme Medical, Inc. · 2011
- 4 generations backK112281 Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire…Trireme Medical, Inc. · 2011
- 3 generations backK121402 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- 2 generations backK122070 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- 1 generation backK130414 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2013
- This deviceK213631 Chocolate PTA Balloon CatheterMedtronic, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −11 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −10 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −9 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −8 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −7 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| −6 | K101062 | Glider Pta Balloon Catheter | Trireme Medical, Inc. | 2010 | — |
| −5 | K103534 | Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire | Trireme Medical, Inc. | 2011 | — |
| −4 | K112281 | Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx… | Trireme Medical, Inc. | 2011 | — |
| −3 | K121402 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta… | Trireme Medical, Inc. | 2012 | — |
| −2 | K122070 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta… | Trireme Medical, Inc. | 2012 | — |
| −1 | K130414 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta… | Trireme Medical, Inc. | 2013 | — |
| 0 (this device) | K213631 | Chocolate PTA Balloon Catheter | Medtronic, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K130414 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Summary page 4…Classification Panel Cardiovascular Product Code LIT Primary Predicate Device Chocolate PTA Balloon Catheter Primary Predicate 510(k) K130414 Number Chocolate PTA Balloon Catheter 510(k) Summary Primary Predicate 21 CFR 870… | 2013 |
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 21 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 43 ancestors have 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. 2021, 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 Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
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/K213631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213631: Chocolate PTA Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213631
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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