510(k) · Cleared
ClearedEMBOLD Fibered Detachable Coil System
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 Apr 12, 2022 as substantially equivalent to K132578 (Boston Scientific Corp, 2013) after a 176-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Apr 12, 2022
- Review
- 176 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K060078 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK060078 Fibered Idc Occlusion SystemBoston Scientific Corporation · 2006
- 2 generations backK102912 Interlock Fibered Idc Occlusion SystemBoston Scientific · 2011
- 1 generation backK132578 Interlock - 18 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013
- This deviceK213398 EMBOLD Fibered Detachable Coil SystemBoston Scientific Corporation · 2022
- Descendant · cites it directly · 0 of its ownK230706 EMBOLD™ Soft Detachable Coil SystemBoston Scientific Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K230706EMBOLD™ Soft Detachable Coil SystemBoston Scientific Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060078 | Fibered Idc Occlusion System | Boston Scientific Corporation | 2006 | — |
| −2 | K102912 | Interlock Fibered Idc Occlusion System | Boston Scientific | 2011 | — |
| −1 | K132578 | Interlock - 18 Fibered Idc Occlusion System | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K213398 | EMBOLD Fibered Detachable Coil System | Boston Scientific Corporation | 2022 | — |
| +1 | K230706 | EMBOLD™ Soft Detachable Coil System | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K132578 | Interlock - 18 Fibered Idc Occlusion SystemSummary page 5…Embolization III. PREDICATE DEVICE IDENTIFICATION Name of Predicate Device Interlock™ Fibered IDC™ Occlusion System (K132578, Cleared September 13, 2013) Predicate device referenced above has not been subject to a design-related recall. IV. DEVICE DESCR… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230706 | EMBOLD™ Soft Detachable Coil System | 2023 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230706 (Boston Scientific Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132578.
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?
The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature.
This device is not intended for coronary or neurovascular use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213398: EMBOLD Fibered Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213398
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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