510(k) · Cleared
ClearedGel-Block Embolization Pledgets
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 May 14, 2012 as substantially equivalent to K991549 (Biosphere Medical, 2000) and 1 other predicate after a 192-day review. Its family tree reaches back 5 generations to 2001. 8 later devices descend from it.
- Decided
- May 14, 2012
- Review
- 192 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010026 (2001). 12 ancestors in all, the oldest K871047 (1987). 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
- 4 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
- 3 generations backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
- 2 generations backK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
- 1 generation backK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- This deviceK113266 Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK143038 Gel-Block 10X embolization pledgetsVascular Solutions, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK133237 Gel-Bead Embolization SpheresVascular Solutions, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK181021 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2018
- Descendant · cites it directly · 1 of its ownK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018
- Descendant · 2 generations on · 1 of its ownK171946 Gel-BeadVascular Solutions, Inc. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc. · 2014 · cites it directly2descendants
- K133237Gel-Bead Embolization SpheresVascular Solutions, Inc. · 2014 · cites it directly2descendants
- K181021EmboCube Embolization GelatinBiosphere Medical, S.A. · 2018 · 2 generations on1descendant
- K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical · 2018 · cites it directly1descendant
- K171946Gel-BeadVascular Solutions, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010026 | Embogold Microsphere | Biosphere Medical, Inc. | 2001 | — |
| −4 | K023089 | Gelspheres Embolic Agent | Biocure, Inc. | 2002 | — |
| −3 | K033761 | Gelspheres / Beadblock Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −2 | K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −1 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| 0 (this device) | K113266 | Gel-Block Embolization Pledgets | Vascular Solutions, Inc. | 2012 | — |
| +1 | K143038 | Gel-Block 10X embolization pledgets | Vascular Solutions, Inc. | 2014 | — |
| +1 | K133237 | Gel-Bead Embolization Spheres | Vascular Solutions, Inc. | 2014 | — |
| +2 | K181021 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2018 | — |
| +1 | K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE… | Shape Memory Medical | 2018 | — |
| +2 | K171946 | Gel-Bead | Vascular Solutions, Inc. | 2017 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K991549 | Embosphere MicrospheresSummary page 1…Device, vascular, for promoting embolization Classification Name 870.3300; KRD; vascular embolization device; Class 11 Predicate Devices K99 1549: Embosphere Microspheres (BioSphere Medical, Inc.) K052742: QuadraSphere Microspheres (BioSphere… | 2000 |
| * | K052742 | Hepasphere MicrospheresSummary page 1…; KRD; vascular embolization device; Class 11 Predicate Devices K99 1549: Embosphere Microspheres (BioSphere Medical, Inc.) K052742: QuadraSphere Microspheres (BioSphere Medical, Inc.) Device Description The Gel-Bloc… | 2006 |
What descends from it? (8)
3 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 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K143038 (Vascular Solutions, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K991549.
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. 2012, 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?
The Gel-Block Embolization Pledgets are intended for use in embolization of hypervascularized tumors and arteriovenous malformations (AVMs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113266: Gel-Block Embolization Pledgets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113266
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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