510(k) · Cleared
Recalled · Class I · 2024GEM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obsidio, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Jul 1, 2022 as substantially equivalent to K183120 (Biosphere Medical, S.A., 2019) after a 261-day review. Its family tree reaches back 6 generations to 1996. 1 of the 13 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jul 1, 2022
- Review
- 261 days
- Class
- Class II
- Product code
- KRD
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961923 (1996). 9 ancestors in all, the oldest K871047 (1987). 3 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 5 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 4 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 3 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 2 generations backK181300 Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · Recalled
- 1 generation backK183120 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019
- This deviceK213385 GEMObsidio, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK242507 OBSIDIO™ Conformable EmbolicBoston Scientific · 2024
- Descendant · 2 generations on · 0 of its ownK261488 OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK253376 OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K242507OBSIDIO™ Conformable EmbolicBoston Scientific · 2024 · cites it directly2descendants
- K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026 · 2 generations on0descendants
- K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −5 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −4 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −3 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −2 | K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 | 1 |
| −1 | K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019 | — |
| 0 (this device) | K213385 | GEM | Obsidio, Inc. | 2022 | — |
| +1 | K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific | 2024 | — |
| +2 | K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026 | — |
| +2 | K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | Boston Scientific Corporation | 2025 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K183120 | EmboCube Embolization GelatinSummary page 4…e Vascular Embolization Device Classification Name Device, Vascular, For Promoting Embolization Predicate Devices Biosphere Medical, S.A. EmboCube™ Embolization Gelatin (K183120) Intended Use / Indications for Use Obsidio GEMTM is indicated for use in the embolization of: • Hypervascular tumors •… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242507 | OBSIDIO™ Conformable Embolic | 2024 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2024 | Class I | Z-1374-2024 | Under Investigation by firm | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K242507 (Boston Scientific, 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K183120.
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. 2022, 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?
Obsidio GEM™ 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/K213385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213385: GEM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213385
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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