510(k) · Cleared
Recalled · Class II · 2016PaxWire Occlusion Balloon System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accessclosure, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Aug 14, 2015 as substantially equivalent to K132990 (Boston Scientific Corp, 2013) and 1 other predicate after a 238-day review. Its family tree reaches back 2 generations to 2006. It has been recalled once.
- Decided
- Aug 14, 2015
- Review
- 238 days
- Class
- Class II
- Product code
- MJN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K062202 (2006). 3 ancestors in all, the oldest K930622 (1993). 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 | K062202 | Occlusion Balloon | Boston Scientific Corp | 2006 | — |
| −1 | K132990 | Occlusion Balloon Catheter | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K143613 | PaxWire Occlusion Balloon System | Accessclosure, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K132990 | Occlusion Balloon CatheterSummary page 5…Page 1 of 4 Predicate Device: Primary: Berenstein Occlusion Balloon Catheter (“Berenstein Catheter”) Boston Scientific Corp. K132990 Secondary: Amplatz Super Stiff Guidewire (“Amplatz Guidewire”) Meadox Medicals, a Division of Boston Scientific Corp. K930622 D… | 2013 |
| * | K930622 | Amplatz GuidewiresSummary page 5…enstein Catheter”) Boston Scientific Corp. K132990 Secondary: Amplatz Super Stiff Guidewire (“Amplatz Guidewire”) Meadox Medicals, a Division of Boston Scientific Corp. K930622 Device Description: The PaxWire™ Occlusion Balloon System (PaxWire System) is designed for use in the iliofemoral artery to pro… | 1993 |
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 |
|---|---|---|---|---|
| Oct 6, 2016 | Class II | Z-0297-2017 | Device Design | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. This is a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 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. 2015, 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 PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery.
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/K143613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143613: PaxWire Occlusion Balloon System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143613
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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