510(k) · Cleared
ClearedModification to Guarddog Occlusion System
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 Aug 11, 2006 as substantially equivalent to K031357 (Possis Medical, Inc., 2004) after a 9-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Aug 11, 2006
- Review
- 9 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972777 (1998). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972777 Temporary Occlusion Balloon SystemPercu Surge, Inc. · 1998
- 1 generation backK031357 Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog…Possis Medical, Inc. · 2004
- This deviceK062220 Modification to Guarddog Occlusion SystemPossis Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK081454 Guarddog Occlusion Guidewire, Inflation DevicePossis Medical, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081454Guarddog Occlusion Guidewire, Inflation DevicePossis Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972777 | Temporary Occlusion Balloon System | Percu Surge, Inc. | 1998 | — |
| −1 | K031357 | Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion… | Possis Medical, Inc. | 2004 | — |
| 0 (this device) | K062220 | Modification to Guarddog Occlusion System | Possis Medical, Inc. | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K031357 | Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion System…Summary page 1…ular Clamp Product Code: MJN Device/ Classification Class 11/21 CFR 870.4450 Cardiovascular and Code: Predicate Device: The GuardDOG Occlusion System - K03 1357 Possis Medical, Inc. 9055 Evergreen Boulevard N.W.… | 2004 |
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 |
|---|---|---|---|
| K081454 | Guarddog Occlusion Guidewire, Inflation Device | 2008 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K081454 (Possis Medical, Inc., 2008) has gone furthest, with 0 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 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/K062220 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062220: Modification to Guarddog Occlusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062220
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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