510(k) · Cleared
Recalled · 2010Techdevice Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techdevice Corporation · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Feb 24, 2006 as substantially equivalent to K021721 (Boston Scientific Corp, 2002) after a 296-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 24, 2006
- Review
- 296 days
- Class
- Class II
- Product code
- MJN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021721 (2002). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K094048Percupro Messenger Balloon CatheterCardiosolutions, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021721 | Equalizer Balloon Catheter | Boston Scientific Corp | 2002 | 4 |
| 0 (this device) | K051137 | Techdevice Occlusion Balloon Catheter | Techdevice Corporation | 2006 | — |
| +1 | K094048 | Percupro Messenger Balloon Catheter | Cardiosolutions, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K021721 | Equalizer Balloon CatheterSummary page 1…tion: Catheter, IntravascLilar Occluding, Temporary (Class II); MJN /21 CFR 870.1250 Predicate Devices Equalizer Balloon Catheter (K021721) Boston Scientific Corporation Natick, MA 01760 Product Descrlption: The occl… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K094048 | Percupro Messenger Balloon Catheter | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2010 | Not classified | Z-0322-2011 | Labeling design | Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on: " Default ECG Lead Behavior " Synchronized Cardioversion using External Paddles |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051137: Techdevice Occlusion 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/K051137
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