510(k) · Cleared
ClearedArteria Occlusion Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arteria Medical Science, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Oct 28, 2002 as substantially equivalent to K990487 (Micro Therapeutics, Inc., 1999) and 1 other predicate after a 194-day review. Its family tree reaches back 1 generation to 1999. 2 of the 9 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Oct 28, 2002
- Review
- 194 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990487 (1999). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK990487 Equinox Occlusion Balloon SystemMicro Therapeutics, Inc. · 1999
- This deviceK021210 Arteria Occlusion BalloonArteria Medical Science, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK230402 ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK123156 Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · cites it directly5descendants
- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · 2 generations on2descendants
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 3 generations on1descendant
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on0descendants
- K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990487 | Equinox Occlusion Balloon System | Micro Therapeutics, Inc. | 1999 | — |
| 0 (this device) | K021210 | Arteria Occlusion Balloon | Arteria Medical Science, Inc. | 2002 | — |
| +1 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +2 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +3 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
| +4 | K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023 | Class I |
| +2 | K123156 | Gore Flow Reversal System Model GFRS073 | W. L. Gore & Associates, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2023 | 1 | 1 |
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.
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? (2)
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 |
|---|---|---|---|
| * | K990487 | Equinox Occlusion Balloon SystemSummary page 1…Catheter Classification Name: Catheter, Intravascular Occluding Temporary Predicate Devices MicroTherapeutics, Inc., EquinoxTMOcclusion Balloon Catheter, K990487 MicroTherapeutics, Inc., HyperFonnTMOcclusion Balloon Catheter, KO1 1656 Description of Device The ArteriA Occlusion… | 1999 |
| * | K011656 | Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771 | 2001 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083300 | Gore Flow Reversal System | 2009 | 5 |
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 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 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 ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels, The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021210 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021210: Arteria Occlusion Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021210
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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