510(k) · Cleared
ClearedEmbosphere Microspheres
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 May 16, 2025 as substantially equivalent to K181300 (Biosphere Medical, S.A., 2018) after a 46-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- May 16, 2025
- Review
- 46 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961923 (1996). 8 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 4 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 3 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 2 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 1 generation backK181300 Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · Recalled
- This deviceK250971 Embosphere MicrospheresBiosphere Medical, S.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −4 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −3 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −2 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −1 | K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 | 1 |
| 0 (this device) | K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 2025 | — |
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.
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 |
|---|---|---|---|
| * | K181300 | Embosphere MicrospheresSummary page 5…ospheres Predicate Device Classification Name Vascular Embolization Device Premarket Notification K181300 Manufacturer Biosphere Medical, S.A. Class… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K181300.
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. 2025, 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?
Embosphere Microspheres are indicated for use in the embolization of:
-Hypervascular tumors, including symptomatic uterine fibroids
-Prostatic arteries for symptomatic Benign Prostatic Hyperplasia (BPH)
-Arteriovenous malformations
-Blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250971: Embosphere Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250971
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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