510(k) · Cleared
Recalled · Class II · 2015Renovocath RC120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovorx, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Oct 24, 2014 as substantially equivalent to K112219 (Thermopeutix, Inc., 2011) after a 171-day review. Its family tree reaches back 6 generations to 1995. It has been recalled once.
- Decided
- Oct 24, 2014
- Review
- 171 days
- Class
- Class II
- Product code
- MJN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953533 (1995). 22 ancestors in all, the oldest K811742 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 5 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 4 generations backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- 3 generations backK080563 Runthrough NS Extension WireTerumo Medical Corp. · 2008
- 2 generations backK093647 Traxcess Docking WireMicroVention, Inc. · 2010
- 1 generation backK112219 Tapas CatheterThermopeutix, Inc. · 2011
- This deviceK141175 Renovocath RC120Renovorx, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −5 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −4 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| −3 | K080563 | Runthrough NS Extension Wire | Terumo Medical Corp. | 2008 | — |
| −2 | K093647 | Traxcess Docking Wire | MicroVention, Inc. | 2010 | — |
| −1 | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | — |
| 0 (this device) | K141175 | Renovocath RC120 | Renovorx, Inc. | 2014 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K112219 | Tapas CatheterSummary page 4…lassification: 21 CFR§870.4450, Vascular clamp Product Code: MJN, Catheter, Intravascular Occluding, Temporary PREDICATE DEVICE(S) ThermopeutiX, Inc. TAPAS Catheters (K112219) (“TAPAS Catheter”) INDICATIONS FOR USE The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2015 | Class II | Z-0565-2016 | Labeling Change Control | Incorrect version of Instructions for Use were shipped to two US customers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 22 ancestors have a recall of any class.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm…
Read the full statement (122 words)
The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.
The RenovoCath™ RC120 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/K141175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141175: Renovocath RC120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141175
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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