510(k) · Cleared
ClearedInterlocking Detachable Coil System (Idc)
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 Apr 13, 2004 as substantially equivalent to K911779 (Target Therapeutics, 1991) and 3 other predicates after a 61-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Apr 13, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K891688 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K141378Idc Interlocking Detachable CoilBoston Scientific Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| 0 (this device) | K040342 | Interlocking Detachable Coil System (Idc) | Boston Scientific Corp | 2004 | — |
| +1 | K141378 | Idc Interlocking Detachable Coil | Boston Scientific Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K911779 | Helix Shaped Coils with Dacron Fibers, ModifiedSummary page 1…Date Coil Pusher K91 1779 Boston Scientific Target K914786 Coil Pusher - 1… | 1991 |
| * | K914786 | Target Therapeutics CoilsSummary page 1…Coil Pusher K91 1779 Boston Scientific Target K914786 Coil Pusher - 16 K891688 Boston Scientif… | 1992 |
| * | K891688 | Coil and Coil Delivery SystemSummary page 1…Boston Scientific Target K914786 Coil Pusher - 16 K891688 Boston Scientific Target GDC Coil Boston Scientific Ta… | 1989 |
| * | K901721 | Modified Target Therapeutics CoilsSummary page 1…Occlusion Coils K91 4786 Boston Scientific Target K901 721 K911779… | 1990 |
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 |
|---|---|---|---|
| K141378 | Idc Interlocking Detachable Coil | 2014 | 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?
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 IDC System is indited 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/K040342 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040342: Interlocking Detachable Coil System (Idc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040342
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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