510(k) · Cleared
ClearedRenovoCath
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 Aug 23, 2021 as substantially equivalent to K191606 (Renovorx, Inc., 2019) after a 28-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Aug 23, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021721 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK021721 Equalizer Balloon CatheterBoston Scientific Corp · 2002 · Recalled
- 3 generations backK140273 Equalizer Occlusion Balloon CatheterBoston Scientific Corp · 2014
- 2 generations backK160067 RenovoCathRenovorx, Inc. · 2017
- 1 generation backK191606 RenovoCathRenovorx, Inc. · 2019
- This deviceK212324 RenovoCathRenovorx, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021721 | Equalizer Balloon Catheter | Boston Scientific Corp | 2002 | 4 |
| −3 | K140273 | Equalizer Occlusion Balloon Catheter | Boston Scientific Corp | 2014 | — |
| −2 | K160067 | RenovoCath | Renovorx, Inc. | 2017 | — |
| −1 | K191606 | RenovoCath | Renovorx, Inc. | 2019 | — |
| 0 (this device) | K212324 | RenovoCath | Renovorx, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K191606 | RenovoCathSummary page 4…cular Occluding, Temporary Classification 21 CFR§870.4450, Vascular clamp Product Code MJN, Catheter, Intravascular Occluding, Temporary PREDICATE DEVICE RenovoCath© (K191606) INDICATIONS FOR USE The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and… | 2019 |
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 19 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has 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. 2021, 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 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 is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and…
Read the full statement (108 words)
The RenovoCath 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 is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 3mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
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/K212324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212324: RenovoCath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212324
Report an extraction error
Are you the manufacturer?
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