510(k) · Cleared
ClearedNitinol Enhanced Device (NED)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embolization, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on May 15, 2025 as substantially equivalent to K132578 (Boston Scientific Corp, 2013) after a 104-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- May 15, 2025
- Review
- 104 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K060078 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK060078 Fibered Idc Occlusion SystemBoston Scientific Corporation · 2006
- 2 generations backK102912 Interlock Fibered Idc Occlusion SystemBoston Scientific · 2011
- 1 generation backK132578 Interlock - 18 Fibered Idc Occlusion SystemBoston Scientific Corp · 2013
- This deviceK250276 Nitinol Enhanced Device (NED)Embolization, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060078 | Fibered Idc Occlusion System | Boston Scientific Corporation | 2006 | — |
| −2 | K102912 | Interlock Fibered Idc Occlusion System | Boston Scientific | 2011 | — |
| −1 | K132578 | Interlock - 18 Fibered Idc Occlusion System | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K132578 | Interlock - 18 Fibered Idc Occlusion SystemSummary page 6…0276 Page 2 of 8 5. LEGALLY MARKETED PREDICATE / REFERENCE DEVICES Predicate Device: K132578 - Interlock-18 Fibered Interlocking Detachable Coil (IDC) Occlusion System (Boston Scientific Corporation) Reference Device: K141… | 2013 |
| † | K141378 | Idc Interlocking Detachable Coil | 2014 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K132578.
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. 2025, 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 Nitinol Enhanced Device (NED) is intended for arterial and venous embolization 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/K250276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250276: Nitinol Enhanced Device (NED).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250276
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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