510(k) · Decided
DecidedTemporary Occlusion Balloon System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Percu Surge, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Mar 11, 1998 after a 229-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Mar 11, 1998
- Review
- 229 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK972777 Temporary Occlusion Balloon SystemPercu Surge, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK031357 Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog…Possis Medical, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK062220 Modification to Guarddog Occlusion SystemPossis Medical, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK081454 Guarddog Occlusion Guidewire, Inflation DevicePossis Medical, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K031357Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion System…Possis Medical, Inc. · 2004 · cites it directly2descendants
- K062220Modification to Guarddog Occlusion SystemPossis Medical, Inc. · 2006 · 2 generations on1descendant
- K081454Guarddog Occlusion Guidewire, Inflation DevicePossis Medical, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972777 | Temporary Occlusion Balloon System | Percu Surge, Inc. | 1998 | — |
| +1 | K031357 | Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion… | Possis Medical, Inc. | 2004 | — |
| +2 | K062220 | Modification to Guarddog Occlusion System | Possis Medical, Inc. | 2006 | — |
| +3 | K081454 | Guarddog Occlusion Guidewire, Inflation Device | Possis Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031357 | Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion System… | 2004 | 2 |
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?
- Of its descendants, K031357 (Possis Medical, Inc., 2004) has gone furthest, with 2 descendants of its own.
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 PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972777 · printed Nov 3, 2026
Cite this page
510(k) Report. “K972777: Temporary Occlusion Balloon System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K972777
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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