510(k) · Cleared
ClearedGel-Bead Embolization Spheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Apr 25, 2014 as substantially equivalent to K021397 (Biosphere Medical, Inc., 2002) and 1 other predicate after a 186-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it.
- Decided
- Apr 25, 2014
- Review
- 186 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010026 (2001). 14 ancestors in all, the oldest K871047 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
- 5 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
- 4 generations backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
- 3 generations backK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
- 2 generations backK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- 1 generation backK113266 Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
- This deviceK133237 Gel-Bead Embolization SpheresVascular Solutions, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK171946 Gel-BeadVascular Solutions, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK173891 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800…Vascular Solutions, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010026 | Embogold Microsphere | Biosphere Medical, Inc. | 2001 | — |
| −5 | K023089 | Gelspheres Embolic Agent | Biocure, Inc. | 2002 | — |
| −4 | K033761 | Gelspheres / Beadblock Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −3 | K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −2 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| −1 | K113266 | Gel-Block Embolization Pledgets | Vascular Solutions, Inc. | 2012 | — |
| 0 (this device) | K133237 | Gel-Bead Embolization Spheres | Vascular Solutions, Inc. | 2014 | — |
| +1 | K171946 | Gel-Bead | Vascular Solutions, Inc. | 2017 | — |
| +1 | K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2… | Vascular Solutions, Inc. | 2018 | — |
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 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationSummary page 1…embolization spheres Classification Name 870.3300, KRD - Device, vascular, for promoting embolization, Class 11 Predicate Device(s) K021397 - Embosphere Microspheres (Biosphere Medical, lnc./Merit Medical Systems, Inc.)… | 2002 |
| * | K113266 | Gel-Block Embolization PledgetsSummary page 1…s) K021397 - Embosphere Microspheres (Biosphere Medical, lnc./Merit Medical Systems, Inc.) K(113266 - Gel-Block Embolization Pledgets (Vascular Solutions, Inc.) Device Description The Gel-Bead embolization spheres (Gel-Bead) con… | 2012 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K171946 (Vascular Solutions, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K021397.
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. 2014, 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?
Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133237: Gel-Bead Embolization Spheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133237
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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