510(k) · Cleared
ClearedInterlock Fibered Idc Occlusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · KRD Device, Vascular, For Promoting Embolization
Cleared on Mar 3, 2011 as substantially equivalent to K060078 (Boston Scientific Corporation, 2006) after a 153-day review. Its family tree reaches back 1 generation to 2006. 4 later devices descend from it.
- Decided
- Mar 3, 2011
- Review
- 153 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060078 (2006). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK060078 Fibered Idc Occlusion SystemBoston Scientific Corporation · 2006
- This deviceK102912 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 · 2 generations on · 1 of its ownK213398 EMBOLD Fibered Detachable Coil SystemBoston Scientific Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK250276 Nitinol Enhanced Device (NED)Embolization, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK230706 EMBOLD™ Soft Detachable Coil SystemBoston Scientific Corporation · 2023
Most influential descendants
Showing 4 of 4 · See all- K132578Interlock - 18 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013 · cites it directly3descendants
- K213398EMBOLD Fibered Detachable Coil SystemBoston Scientific Corporation · 2022 · 2 generations on1descendant
- K250276Nitinol Enhanced Device (NED)Embolization, Inc. · 2025 · 2 generations on0descendants
- K230706EMBOLD™ Soft Detachable Coil SystemBoston Scientific Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060078 | Fibered Idc Occlusion System | Boston Scientific Corporation | 2006 | — |
| 0 (this device) | K102912 | Interlock Fibered Idc Occlusion System | Boston Scientific | 2011 | — |
| +1 | K132578 | Interlock - 18 Fibered Idc Occlusion System | Boston Scientific Corp | 2013 | — |
| +2 | K213398 | EMBOLD Fibered Detachable Coil System | Boston Scientific Corporation | 2022 | — |
| +2 | K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | 2025 | — |
| +3 | K230706 | EMBOLD™ Soft Detachable Coil System | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (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 |
|---|---|---|---|
| * | K060078 | Fibered Idc Occlusion SystemSummary page 1…bered Interlocking Detachable Coil (Fibered IDC Nameof Pedicte DviceOcclusion System) (K(060078) Confidential and Pmoprietary to Boston Scientific Corporation Page 4 of 24… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132578 | Interlock - 18 Fibered Idc Occlusion System | 2013 | 3 |
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?
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. 2011, 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 Interlock™ 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/K102912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102912: Interlock Fibered Idc Occlusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102912
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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