510(k) · Cleared
ClearedComplex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered Platinum Coils, Vortx -18, Vortx 35 & 2D Helical
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 Feb 11, 2011 as substantially equivalent to K914786 (Target Therapeutics, 1992) and 1 other predicate after a 144-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 11, 2011
- Review
- 144 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914786 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914786 Target Therapeutics CoilsTarget Therapeutics · 1992
- This deviceK102714 Complex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered…Boston Scientific Corp · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914786 | Target Therapeutics Coils | Target Therapeutics | 1992 | — |
| 0 (this device) | K102714 | Complex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered Platinum… | Boston Scientific Corp | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K914786 | Target Therapeutics CoilsSummary page 1…al-35 Fibered Platinum Coils 1) Target Therapeutics Peripheral Coils (K9 14786) Names of Predicate Devices Target Therapeutics Fibered Platinum Coils… | 1992 |
| * | K955293 | Fibered Platinum Coil, .035 TypeSummary page 1…(K9 14786) Names of Predicate Devices Target Therapeutics Fibered Platinum Coils 2) (K955293) SumisionModifications to the device labeling related to Reasn fr Reasn fr SumisionMRI… | 1996 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K914786.
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?
Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102714: Complex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered Platinum Coils, Vortx -18, Vortx 35 & 2D Helical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102714
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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