510(k) · Cleared
ClearedChocolate Ptca Bolloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trireme Medical, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Jun 2, 2014 as substantially equivalent to K111544 (Trireme Medical, Inc., 2012) and 1 other predicate after a 188-day review. Its family tree reaches back 4 generations to 1986. 3 later devices descend from it.
- Decided
- Jun 2, 2014
- Review
- 188 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P860019 (1986). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 3 generations backK110133 Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation…Creganna-Tactx Medical · 2011 · Recalled
- 2 generations backK111544 Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012
- 1 generation backK121681 Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012
- This deviceK133633 Chocolate Ptca Bolloon CatheterTrireme Medical, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK150292 Chocolate PTCA Balloon CatheterTrireme Medical, LLC · 2015
- Descendant · cites it directly · 1 of its ownK153682 Chocolate XD PTCA Balloon CatheterTrireme Medical, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK233729 Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer…Vascular Solutions, LLC · 2024
Most influential descendants
Showing 3 of 3 · See all- K150292Chocolate PTCA Balloon CatheterTrireme Medical, LLC · 2015 · cites it directly2descendants
- K153682Chocolate XD PTCA Balloon CatheterTrireme Medical, LLC · 2016 · cites it directly1descendant
- K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…Vascular Solutions, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −3 | K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | Creganna-Tactx Medical | 2011 | 3 |
| −2 | K111544 | Glider Ptca Balloon Catheter | Trireme Medical, Inc. | 2012 | — |
| −1 | K121681 | Glider Ptca Balloon Catheter | Trireme Medical, Inc. | 2012 | — |
| 0 (this device) | K133633 | Chocolate Ptca Bolloon Catheter | Trireme Medical, Inc. | 2014 | — |
| +1 | K150292 | Chocolate PTCA Balloon Catheter | Trireme Medical, LLC | 2015 | — |
| +1 | K153682 | Chocolate XD PTCA Balloon Catheter | Trireme Medical, LLC | 2016 | — |
| +2 | K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion… | Vascular Solutions, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 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 LOX? 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 LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111544 | Glider Ptca Balloon Catheter | 2012 |
| * | K121681 | Glider Ptca Balloon CatheterSummary page 1…angioplasty (PTCA) catheter [21 CFR 870.5 100(a)] Predicate Device: Glider PTCA Balloon Catheter (TriReme Medical) -( KI 11544 and K1 2168 1) Device Description The Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a… | 2012 |
What descends from it? (3)
2 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)
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 28 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K150292 (Trireme Medical, LLC, 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K111544.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
MAUDE reports naming product code LOX, 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 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
What is it indicated for?
The ChocolateTm PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass gmaft stenosis for the purpose of improving myocardial perfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133633: Chocolate Ptca Bolloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133633
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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