510(k) · Cleared
Recalled · Class II · 2013Transform Occlusion Balloon Catheter (Compliant and Super Compliant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jan 11, 2013 as substantially equivalent to K101570 (Micro Therapeutics Dba Ev3 Neurovascular, 2010) after a 141-day review. Its family tree reaches back 5 generations to 2001. It has been recalled 8 times.
- Decided
- Jan 11, 2013
- Review
- 141 days
- Class
- Class II
- Product code
- MJN
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011526 (2001). 11 ancestors in all, the oldest K990487 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK011526 Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121…Micro Therapeutics, Inc. · 2001
- 4 generations backK090728 Hyperglide Occlusion Balloon SystemEv3, Inc. · 2009
- 3 generations backK092495 Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Ev3 Neurovascular · 2009
- 2 generations backK100063 Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon…Ev3, Inc. · 2010
- 1 generation backK101570 Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular · 2010
- This deviceK122576 Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129… | Micro Therapeutics, Inc. | 2001 | — |
| −4 | K090728 | Hyperglide Occlusion Balloon System | Ev3, Inc. | 2009 | — |
| −3 | K092495 | Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 | Ev3 Neurovascular | 2009 | — |
| −2 | K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter… | Ev3, Inc. | 2010 | — |
| −1 | K101570 | Hyperglide and Hyperform Occlusion Balloon Systems | Micro Therapeutics Dba Ev3 Neurovascular | 2010 | — |
| 0 (this device) | K122576 | Transform Occlusion Balloon Catheter (Compliant and Super Compliant | Stryker Neurovascular | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K101570 | Hyperglide and Hyperform Occlusion Balloon Systems | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2013 | Class II | Z-0505-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Nov 4, 2013 | Class II | Z-0507-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Nov 4, 2013 | Class II | Z-0512-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Nov 4, 2013 | Class II | Z-0508-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Nov 4, 2013 | Class II | Z-0509-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Nov 4, 2013 | Class II | Z-0510-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Nov 4, 2013 | Class II | Z-0511-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Nov 4, 2013 | Class II | Z-0506-2014 | Software Manufacturing/Software Deployment | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- None of the 11 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. 2013, 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 Stryker NeurovascularTransForm Occlusion Balloon Catheters are indicated for use in the neuro and peripheral vasculature to temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122576 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122576: Transform Occlusion Balloon Catheter (Compliant and Super Compliant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122576
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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