510(k) · Cleared
ClearedFibered Idc Occlusion 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 Jan 31, 2006 after a 21-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Jan 31, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK060078 Fibered Idc Occlusion SystemBoston Scientific Corporation · 2006
- Descendant · cites it directly · 4 of its ownK102912 Interlock Fibered Idc Occlusion SystemBoston Scientific · 2011
- Descendant · cites it directly · 3 of its ownK132578 Interlock - 18 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013
- Descendant · cites it directly · 3 of its ownK110295 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011
- Descendant · 2 generations on · 2 of its ownK112103 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011
- Descendant · 2 generations on · 1 of its ownK213398 EMBOLD Fibered Detachable Coil SystemBoston Scientific Corporation · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K102912Interlock Fibered Idc Occlusion SystemBoston Scientific · 2011 · cites it directly4descendants
- K132578Interlock - 18 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013 · cites it directly3descendants
- K110295Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011 · cites it directly3descendants
- K112103Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011 · 2 generations on2descendants
- K213398EMBOLD Fibered Detachable Coil SystemBoston Scientific Corporation · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060078 | Fibered Idc Occlusion System | Boston Scientific Corporation | 2006 | — |
| +1 | K102912 | Interlock Fibered Idc Occlusion System | Boston Scientific | 2011 | — |
| +1 | K132578 | Interlock - 18 Fibered Idc Occlusion System | Boston Scientific Corp | 2013 | — |
| +1 | K110295 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corp | 2011 | — |
| +2 | K112103 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corp | 2011 | — |
| +2 | K213398 | EMBOLD Fibered Detachable Coil System | Boston Scientific Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | — | Interlocking Detachable Coil System (IDC System) Named without a submission number | |
| * | — | Guglielmi Detachable Coil (GDC) Named without a submission number | |
| * | — | GDC VortX Named without a submission number | |
| * | — | VortX-18 Pushable Coils Named without a submission number | |
| * | — | VortX-18 Diamond Pushable Coils Named without a submission number |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K102912 (Boston Scientific, 2011) has gone furthest, with 4 descendants of its own.
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.
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 Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060078: Fibered Idc Occlusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060078
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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