510(k) · Cleared
Recalled · Class II · 2026Embosphere 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 Jul 16, 2018 as substantially equivalent to K021397 (Biosphere Medical, Inc., 2002) after a 60-day review. Its family tree reaches back 4 generations to 1996. 1 of the 17 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- Jul 16, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- KRD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961923 (1996). 7 ancestors in all, the oldest K871047 (1987). 9 later devices descend from it, 2 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 3 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 2 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 1 generation backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- This deviceK181300 Embosphere MicrospheresBiosphere Medical, S.A. · 2018
- Descendant · cites it directly · 7 of its ownK183120 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019
- Descendant · 2 generations on · 3 of its ownK213385 GEMObsidio, Inc. · 2022 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK242507 OBSIDIO™ Conformable EmbolicBoston Scientific · 2024
- Descendant · 2 generations on · 1 of its ownK240873 TEMBO Embolic SystemInstylla, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK261488 OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K213385 GEM2 generations on · 2022
Most influential descendants
Showing 5 of 9 · See all- K183120EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019 · cites it directly7descendants
- K213385GEMObsidio, Inc. · 2022 · 2 generations on3descendants
- K242507OBSIDIO™ Conformable EmbolicBoston Scientific · 2024 · 3 generations on2descendants
- K240873TEMBO Embolic SystemInstylla, Inc. · 2024 · 2 generations on1descendant
- K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −3 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −2 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −1 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| 0 (this device) | K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 | — |
| +1 | K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019 | — |
| +2 | K213385 | GEM | Obsidio, Inc. | 2022 | Class I |
| +3 | K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific | 2024 | — |
| +2 | K240873 | TEMBO Embolic System | Instylla, Inc. | 2024 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationSummary page 4…Embosphere® Microspheres Classification Name: 21 CFR 870.3300 – Vascular Embolization Device Premarket Notification: K021397 Manufacturer: Biosphere Medical, S.A. Predicate Device Reference devices:… | 2002 |
| † | K991549 | Embosphere Microspheres | 2000 |
| † | DEN160040 | Embosphere Microspheres | 2017 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2026 | Class II | Z-3305-2026 | Process control | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection. |
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 on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K183120 (Biosphere Medical, S.A., 2019) has gone furthest, with 7 descendants 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. 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?
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/K181300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181300: 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/K181300
Report an extraction error
Are you the manufacturer?
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