510(k) · Cleared
ClearedInterlock-35 Fibered Idc Occlusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KRD Device, Vascular, For Promoting Embolization
Cleared on Mar 3, 2011 as substantially equivalent to K060078 (Boston Scientific Corporation, 2006) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Mar 3, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955293 (1996). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK955293 Fibered Platinum Coil, .035 TypeTarget Therapeutics · 1996 · Recalled
- This deviceK110295 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011
- Descendant · cites it directly · 2 of its ownK112103 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011
- Descendant · 2 generations on · 1 of its ownK113651 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corporation · 2012
- Descendant · 3 generations on · 0 of its ownK133208 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013
Most influential descendants
Showing 3 of 3 · See all- K112103Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011 · cites it directly2descendants
- K113651Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corporation · 2012 · 2 generations on1descendant
- K133208Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955293 | Fibered Platinum Coil, .035 Type | Target Therapeutics | 1996 | 2 |
| 0 (this device) | K110295 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corp | 2011 | — |
| +1 | K112103 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corp | 2011 | — |
| +2 | K113651 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corporation | 2012 | — |
| +3 | K133208 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corp | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (2)
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…e Classification Class 11 Product Code KRID, Vascular embolization devices (21 OFA 870.3300) Boston Scientific K060078 SE: 31 Jan 2006 Interlock Fibered IDC Predicate Occlusion System Devices Fibered Plat… | 2006 |
| * | K955293 | Fibered Platinum Coil, .035 TypeSummary page 1…ientific K060078 SE: 31 Jan 2006 Interlock Fibered IDC Predicate Occlusion System Devices Fibered Platinum K955293 SE: 6 Feb 1996 .035" Type Occlusion Coils Reason for To gain clearance for a m… | 1996 |
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 |
|---|---|---|---|
| K112103 | Interlock-35 Fibered Idc Occlusion System | 2011 | 2 |
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-35 Fibered IDC Occlusion System is 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/K110295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110295: Interlock-35 Fibered Idc Occlusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110295
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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