510(k) · Cleared
ClearedOBSIDIO Conformable Embolic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KRD Device, Vascular, For Promoting Embolization
Cleared on Jul 24, 2026 as substantially equivalent to K242507 (Boston Scientific, 2024) after a 79-day review. Its family tree reaches back 8 generations to 1996. 1 of the 12 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 24, 2026
- Review
- 79 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K961923 (1996). 11 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 7 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 6 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 5 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 4 generations backK181300 Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · Recalled
- 3 generations backK183120 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019
- 2 generations backK213385 GEMObsidio, Inc. · 2022 · Recalled (Class I)
- 1 generation backK242507 OBSIDIO™ Conformable EmbolicBoston Scientific · 2024
- This deviceK261488 OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026
Class I recalls in this family
- K213385 GEM2 generations back · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −7 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −6 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −5 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −4 | K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 | 1 |
| −3 | K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019 | — |
| −2 | K213385 | GEM | Obsidio, Inc. | 2022 | Class I |
| −1 | K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific | 2024 | — |
| 0 (this device) | K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K242507 | OBSIDIO™ Conformable EmbolicSummary page 5…device Device Embolization III. PREDICATE DEVICE IDENTIFICATION Predicate Device: OBSIDIO™ Conformable Embolic K242507 Reference Device: OBSIDIO™ Conformable Embolic K253376 IV. DEVICE DESCRIPTION The OBSIDIO™ Conformable Em… | 2024 |
| † | K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K213385GEMObsidio, Inc. · 2022 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K242507.
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. 2026, 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 OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:
• Hypervascular tumors
• Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261488: OBSIDIO Conformable Embolic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261488
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026