510(k) · Cleared
ClearedModification to:Contour SE Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · HCG Device, Neurovascular Embolization
Cleared on Jul 12, 2007 after a 27-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Jul 12, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK071634 Modification to:Contour SE MicrospheresBoston Scientific Corp · 2007
- Descendant · cites it directly · 6 of its ownK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK130307 Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML…Celonova Biosciences, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK141209 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K073417Embozene MicrospheresCelonova Biosciences, Inc. · 2008 · cites it directly6descendants
- K132675Embozene MicrospheresCelonova Biosciences, Inc. · 2013 · 2 generations on4descendants
- K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc. · 2014 · 2 generations on2descendants
- K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc. · 2013 · 2 generations on2descendants
- K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071634 | Modification to:Contour SE Microspheres | Boston Scientific Corp | 2007 | — |
| +1 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| +2 | K132675 | Embozene Microspheres | Celonova Biosciences, Inc. | 2013 | — |
| +2 | K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | Celonova Biosciences, Inc. | 2014 | — |
| +2 | K130307 | Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene… | Celonova Biosciences, Inc. | 2013 | — |
| +2 | K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)… | Celonova Biosciences, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2024 | 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 HCG? 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073417 | Embozene Microspheres | 2008 | 6 |
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, K073417 (Celonova Biosciences, Inc., 2008) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
Contour SE Microspheres are indicated for the embolization of hypervascular tumors, including leiomyoma uteri and arteriovenous malformations (AVMs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071634: Modification to:Contour SE Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071634
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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