510(k) · Cleared
ClearedEmboCube Embolization Gelatin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosphere Medical, S.A. · KRD Device, Vascular, For Promoting Embolization
Cleared on Sep 27, 2018 as substantially equivalent to K143038 (Vascular Solutions, Inc., 2014) after a 163-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Sep 27, 2018
- Review
- 163 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010026 (2001). 14 ancestors in all, the oldest K871047 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
- 6 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
- 5 generations backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
- 4 generations backK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
- 3 generations backK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- 2 generations backK113266 Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
- 1 generation backK143038 Gel-Block 10X embolization pledgetsVascular Solutions, Inc. · 2014
- This deviceK181021 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2018
- Descendant · cites it directly · 0 of its ownK183578 Torpedo Gelatin FoamBiosphere Medical, S.A. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183578Torpedo Gelatin FoamBiosphere Medical, S.A. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010026 | Embogold Microsphere | Biosphere Medical, Inc. | 2001 | — |
| −6 | K023089 | Gelspheres Embolic Agent | Biocure, Inc. | 2002 | — |
| −5 | K033761 | Gelspheres / Beadblock Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −4 | K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −3 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| −2 | K113266 | Gel-Block Embolization Pledgets | Vascular Solutions, Inc. | 2012 | — |
| −1 | K143038 | Gel-Block 10X embolization pledgets | Vascular Solutions, Inc. | 2014 | — |
| 0 (this device) | K181021 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2018 | — |
| +1 | K183578 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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 |
|---|---|---|---|
| * | K143038 | Gel-Block 10X embolization pledgetsSummary page 4…on Pledgets Classification Name: 21 CFR § 870.3300 Vascular Embolization Device Premarket Notification: K143038 Manufacturer: Vascular Solutions Predicate and Reference… | 2014 |
| † | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization | 2002 |
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 |
|---|---|---|---|
| K183578 | Torpedo Gelatin Foam | 2019 | 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 17 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K183578 (Biosphere Medical, S.A., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
EmboCube Embolization Gelatin is indicated for use in embolization of hypervascular tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181021: EmboCube Embolization Gelatin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181021
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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