510(k) · Cleared
ClearedContour 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 Aug 22, 2002 after a 28-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Aug 22, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK022427 Contour SE MicrospheresBoston Scientific Corp · 2002
- Descendant · cites it directly · 11 of its ownK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- Descendant · 2 generations on · 8 of its ownK113266 Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 2006 · cites it directly11descendants
- K034068Contour SE MicrospheresBoston Scientific Corp · 2004 · cites it directly10descendants
- K113266Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012 · 2 generations on8descendants
- K073417Embozene MicrospheresCelonova Biosciences, Inc. · 2008 · 2 generations on6descendants
- K132675Embozene MicrospheresCelonova Biosciences, Inc. · 2013 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022427 | Contour SE Microspheres | Boston Scientific Corp | 2002 | — |
| +1 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| +1 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| +2 | K113266 | Gel-Block Embolization Pledgets | Vascular Solutions, Inc. | 2012 | — |
| +2 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| +3 | K132675 | Embozene Microspheres | Celonova Biosciences, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | — | Contour Emboli PVA Named without a submission number | |
| * | — | Embosphere Microspheres Named without a submission number | |
| * | — | EmboGold Microspehers Named without a submission number |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K052742 (Biosphere Medical, Inc., 2006) has gone furthest, with 11 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.
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 SETMMicrospheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022427: Contour SE Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022427
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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