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 Nov 14, 2013 as substantially equivalent to K113651 (Boston Scientific Corporation, 2012) after a 27-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Nov 14, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955293 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK955293 Fibered Platinum Coil, .035 TypeTarget Therapeutics · 1996 · Recalled
- 3 generations backK110295 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011
- 2 generations backK112103 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2011
- 1 generation backK113651 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corporation · 2012
- This deviceK133208 Interlock-35 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955293 | Fibered Platinum Coil, .035 Type | Target Therapeutics | 1996 | 2 |
| −3 | K110295 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corp | 2011 | — |
| −2 | K112103 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corp | 2011 | — |
| −1 | K113651 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corporation | 2012 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K113651 | Interlock-35 Fibered Idc Occlusion SystemSummary page 1…Review Panel: Cardiovascular Predicate Device InterlockTM -35 Fibered IDCTM Occlusion System (K1 13651, January 11, 2013) Intended Use / Indications for Use The lnterlock-35 Fibered IDC Occlusion System is indicated for obstructing… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2013, 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 lnterlock-35 Fibered IDO Occlusion System is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolizalion procedures. This device Is not intended for neurovascular use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133208: 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/K133208
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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