510(k) · Cleared
ClearedTapas Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermopeutix, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Nov 18, 2011 as substantially equivalent to K080700 (Thermopeutix, Inc., 2008) and 1 other predicate after a 108-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Nov 18, 2011
- Review
- 108 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K953533 (1995). 21 ancestors in all, the oldest K811742 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 4 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 3 generations backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- 2 generations backK080563 Runthrough NS Extension WireTerumo Medical Corp. · 2008
- 1 generation backK093647 Traxcess Docking WireMicroVention, Inc. · 2010
- This deviceK112219 Tapas CatheterThermopeutix, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK141175 Renovocath RC120Renovorx, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K141175Renovocath RC120Renovorx, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −4 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −3 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| −2 | K080563 | Runthrough NS Extension Wire | Terumo Medical Corp. | 2008 | — |
| −1 | K093647 | Traxcess Docking Wire | MicroVention, Inc. | 2010 | — |
| 0 (this device) | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | — |
| +1 | K141175 | Renovocath RC120 | Renovorx, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 MJN? 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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 |
|---|---|---|---|
| * | K080700 | Duoflo CatheterSummary page 1…scular Clamp (Product Code MJN). Proprietary Name: TAPAS M Catheters Predicate Device The Predicate device isthe ThermopeutiX DuoFloTM catheter cleared via Slok's K080700 and K093647. TAPASW Catheter The ThermopeutiX TAPAS" Catheter utilizes the identical materials, design and construction methods t… | 2008 |
| * | K093647 | Traxcess Docking WireSummary page 1…(Product Code MJN). Proprietary Name: TAPAS M Catheters Predicate Device The Predicate device isthe ThermopeutiX DuoFloTM catheter cleared via Slok's K080700 and K093647. TAPASW Catheter The ThermopeutiX TAPAS" Catheter utilizes the identical materials, design and construction methods that are used… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141175 | Renovocath RC120 | 2014 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K141175 (Renovorx, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080700.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ThermopeutiX TAPASTM Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
The TAPASTM Catheter is contraindicated for use in the coronary and intracranial arteries.
The TAPASM Catheter is not intended for embolic protection or as an aspiration catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112219: Tapas Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112219
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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