510(k) · Cleared
ClearedAortaSTAT Occlusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renalpro Medical, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jul 9, 2021 as substantially equivalent to K183679 (Qxmedical, LLC, 2019) after a 130-day review. Its family tree reaches back 4 generations to 2002. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 9, 2021
- Review
- 130 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. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK021721 Equalizer Balloon CatheterBoston Scientific Corp · 2002 · Recalled
- 3 generations backK140273 Equalizer Occlusion Balloon CatheterBoston Scientific Corp · 2014
- 2 generations backK153530 Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · Recalled (Class I)
- 1 generation backK183679 Occlusion Balloon CatheterQxmedical, LLC · 2019
- This deviceK210602 AortaSTAT Occlusion DeviceRenalpro Medical, Inc. · 2021
Class I recalls in this family
- K153530 Bridge Occlusion Balloon2 generations back · 2016
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 | K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016 | Class I |
| −1 | K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019 | — |
| 0 (this device) | K210602 | AortaSTAT Occlusion Device | Renalpro Medical, 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K183679 | Occlusion Balloon CatheterSummary page 4…ion Name: Vascular Clamp Regulatory Class: Class II Regulation Number: 21 CFR 870.4450 Product Code: MJN Predicate Device: QXMedical, LLC Occlusion Balloon Catheter (K183679) Reference Device: Roxwood Medical, Inc. CenterCross Catheter (K140910) Device Description: The RenalPro Medical AortaSTAT Occ… | 2019 |
| † | K140910 | Centercross Catheter | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153530Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · 2 generations back · ◆ on the line of descent in FIG. 11 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 3.2 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K183679.
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 AortaSTAT Occulsion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage
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/K210602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210602: AortaSTAT Occlusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210602
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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