510(k) · Cleared
ClearedGuarddog Occlusion Guidewire, Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Possis Medical, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jun 13, 2008 as substantially equivalent to K062220 (Possis Medical, Inc., 2006) after a 21-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jun 13, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972777 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK972777 Temporary Occlusion Balloon SystemPercu Surge, Inc. · 1998
- 2 generations backK031357 Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog…Possis Medical, Inc. · 2004
- 1 generation backK062220 Modification to Guarddog Occlusion SystemPossis Medical, Inc. · 2006
- This deviceK081454 Guarddog Occlusion Guidewire, Inflation DevicePossis Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972777 | Temporary Occlusion Balloon System | Percu Surge, Inc. | 1998 | — |
| −2 | K031357 | Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion… | Possis Medical, Inc. | 2004 | — |
| −1 | K062220 | Modification to Guarddog Occlusion System | Possis Medical, Inc. | 2006 | — |
| 0 (this device) | K081454 | Guarddog Occlusion Guidewire, Inflation Device | Possis Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K062220 | Modification to Guarddog Occlusion SystemSummary page 1…Vascular Clamp Product Code: MJN Device/ Classification Class 11/21 CFR 870.4450 Cardiovascular and Code: Predicate Device: The GuardDOG Occlusion System - K062220 Possis Medical, Inc. 9055 Evergreen Boulevard N.W. Min… | 2006 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 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. 2008, 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 GuardDOG Occlusion 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081454: Guarddog Occlusion Guidewire, Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081454
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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