510(k) · Cleared
ClearedREBOA Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuMED, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jun 20, 2016 as substantially equivalent to K041306 (NuMED, Inc., 2004) and 4 other predicates after a 110-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Jun 20, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K093911 (2010). 5 ancestors in all, the oldest K041306 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093911 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2010 | — |
| −1 | K152762 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2015 | — |
| 0 (this device) | K160598 | REBOA Balloon Catheter | NuMED, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K041306 | Numed PTS X Sizing Balloon CatheterSummary page 4…Name: REBOA Catheter Common Name: Catheter, Intravascular Occluding, Temporary Classification Name: Catheter, Intravascular Occluding, Temporary PTS-X PTV Catheter — K041306, K110903, and K131869 Class 11, 21 CFR 870.4450 — Product Code MIN Fogarty Occlusion Catheter — K152762 and K093911 Class 11, 21… | 2004 |
| * | K110903 | PTS-X Sizing Balloon CatheterSummary page 4…BOA Catheter Common Name: Catheter, Intravascular Occluding, Temporary Classification Name: Catheter, Intravascular Occluding, Temporary PTS-X PTV Catheter — K041306, K110903, and K131869 Class 11, 21 CFR 870.4450 — Product Code MIN Fogarty Occlusion Catheter — K152762 and K093911 Class 11, 21 CFR 870.… | 2011 |
| * | K131869 | PTS-X Sizing Balloon CatheterSummary page 4…Common Name: Catheter, Intravascular Occluding, Temporary Classification Name: Catheter, Intravascular Occluding, Temporary PTS-X PTV Catheter — K041306, K110903, and K131869 Class 11, 21 CFR 870.4450 — Product Code MIN Fogarty Occlusion Catheter — K152762 and K093911 Class 11, 21 CFR 870.4450 — Produc… | 2013 |
| * | K152762 | Fogarty Occlusion CatheterSummary page 4…theter, Intravascular Occluding, Temporary PTS-X PTV Catheter — K041306, K110903, and K131869 Class 11, 21 CFR 870.4450 — Product Code MIN Fogarty Occlusion Catheter — K152762 and K093911 Class 11, 21 CFR 870.4450 — Product Code MIN Class 11, 21 CFR 870.4450 — Product Code MIN Performance Standards hav… | 2015 |
| * | K093911 | Fogarty Occlusion CatheterSummary page 4…avascular Occluding, Temporary PTS-X PTV Catheter — K041306, K110903, and K131869 Class 11, 21 CFR 870.4450 — Product Code MIN Fogarty Occlusion Catheter — K152762 and K093911 Class 11, 21 CFR 870.4450 — Product Code MIN Class 11, 21 CFR 870.4450 — Product Code MIN Performance Standards have not been e… | 2010 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Recommended for temporary occlusion of the aorta.
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/K160598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160598: REBOA Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160598
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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