510(k) · Cleared
ClearedLdob Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Mar 22, 2001 after a 238-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 63 devices in its family, counting itself, have a Class I recall. 62 later devices descend from it.
- Decided
- Mar 22, 2001
- Review
- 238 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 0
62 later devices descend from it, 6 citing it directly. 2 of the 63 devices in this family, counting this one, have a Class I recall.
- This deviceK002286 Ldob Occlusion Balloon CatheterCook, Inc. · 2001
- Descendant · cites it directly · 26 of its ownK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- Descendant · cites it directly · 25 of its ownK041151 Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004
- Descendant · 2 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- Descendant · 3 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
- Descendant · 2 generations on · 11 of its ownK122917 Coda Balloon CatheterCook, Inc. · 2013
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 62 · See all- K032869Cook Coda Balloon CatheterCook, Inc. · 2003 · cites it directly26descendants
- K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004 · cites it directly25descendants
- K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 2 generations on24descendants
- K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 3 generations on14descendants
- K122917Coda Balloon CatheterCook, Inc. · 2013 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002286 | Ldob Occlusion Balloon Catheter | Cook, Inc. | 2001 | — |
| +1 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| +1 | K041151 | Kerberos Occluding Guide Catheter and Accessories | Kerberos Proximal Solutions, Inc. | 2004 | — |
| +2 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| +3 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 1 |
| +2 | K122917 | Coda Balloon Catheter | Cook, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 9 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 1 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 1 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (62)
See all 626 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032869 | Cook Coda Balloon Catheter | 2003 | 26 |
| K041151 | Kerberos Occluding Guide Catheter and Accessories | 2004 | 25 |
| K050038 | Reliant Stent Graft Balloon Catheter | 2005 | 11 |
| K033670 | Gore Tri-Lobe Balloon Catheter | 2004 | 7 |
| K070770 | Gore Balloon Sheath | 2007 | 6 |
| K052844 | Kavs - Catheter, Models 1107100 & 1107060 | 2006 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K032869 (Cook, Inc., 2003) has gone furthest, with 26 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 | — |
https://510kreport.com/device/K002286 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002286: Ldob Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002286
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026