510(k) · Cleared
ClearedNexus Detachable Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · HCG Device, Neurovascular Embolization
Cleared on Apr 27, 2005 as substantially equivalent to K041649 (Micro Therapeutics, Inc., 2004) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1990. 27 later devices descend from it.
- Decided
- Apr 27, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K901337 (1990). 8 ancestors in all. 27 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK901337 Hilal Embolization Microcoil (TM)Cook, Inc. · 1990 · Recalled
- 2 generations backK033372 Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone…Micro Therapeutics, Inc. · 2004
- 1 generation backK041649 Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004
- This deviceK050543 Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005
- Descendant · cites it directly · 24 of its ownK051560 Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
- Descendant · cites it directly · 24 of its ownK051425 Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
- Descendant · cites it directly · 23 of its ownK060747 FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 22 of its ownK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · cites it directly24descendants
- K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · cites it directly24descendants
- K060747FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007 · cites it directly23descendants
- K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · 2 generations on22descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901337 | Hilal Embolization Microcoil (TM) | Cook, Inc. | 1990 | 2 |
| −2 | K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models | Micro Therapeutics, Inc. | 2004 | — |
| −1 | K041649 | Sapphire NXT Detachable Coil System | Micro Therapeutics, Inc. | 2004 | — |
| 0 (this device) | K050543 | Nexus Detachable Coil System | Micro Therapeutics, Inc. | 2005 | — |
| +1 | K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR | Micro Therapeutics, Inc. | 2005 | — |
| +1 | K051425 | Nexus Detachable Coil System, Helix Super Soft CSR | Micro Therapeutics, Inc. | 2005 | — |
| +1 | K060747 | FX Detachable Coil System | Micro Therapeutics, Inc. | 2007 | 2 |
| +2 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| +3 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 HCG? 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 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 |
|---|---|---|---|
| * | K041649 | Sapphire NXT Detachable Coil SystemSummary page 1…DesrptcPredicate For Clerance Date K04 1649 ~Sapphire NXT Detachable Nexus Detachable Coil System July 16, 2004 Coil System K012985… | 2004 |
| * | K012985 | Matrix Detachable CoilsSummary page 1…Date K04 1649 ~Sapphire NXT Detachable Nexus Detachable Coil System July 16, 2004 Coil System K012985 Boston Scientific Target, Nexus Detachable Coil System Sept 06, 2001 Matrix Detachable Coil… | 2002 |
What descends from it? (27)
See all 274 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K051560 (Micro Therapeutics, Inc., 2005) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K041649.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050543 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050543: Nexus Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050543
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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