510(k) · Cleared
ClearedNexus Detachable Coil System, Morpheus 3D CSR
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 20, 2006 as substantially equivalent to K050543 (Micro Therapeutics, Inc., 2005) after a 42-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Apr 20, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901337 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK901337 Hilal Embolization Microcoil (TM)Cook, Inc. · 1990 · Recalled
- 3 generations backK033372 Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone…Micro Therapeutics, Inc. · 2004
- 2 generations backK041649 Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004
- 1 generation backK050543 Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005
- This deviceK060625 Nexus Detachable Coil System, Morpheus 3D CSRMicro Therapeutics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901337 | Hilal Embolization Microcoil (TM) | Cook, Inc. | 1990 | 2 |
| −3 | K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models | Micro Therapeutics, Inc. | 2004 | — |
| −2 | K041649 | Sapphire NXT Detachable Coil System | Micro Therapeutics, Inc. | 2004 | — |
| −1 | K050543 | Nexus Detachable Coil System | Micro Therapeutics, Inc. | 2005 | — |
| 0 (this device) | K060625 | Nexus Detachable Coil System, Morpheus 3D CSR | Micro Therapeutics, Inc. | 2006 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K050543 | Nexus Detachable Coil SystemSummary page 1…rnia 92618 Contact: Florin Truuvert Predicate Device: 14umber ~ De scienption PredicateFor ~ ClearanceiDate- K050543 Nexus Detachable Coils, Nexus Detachable Coil, April 27, 2005 Tetris 3D… | 2005 |
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 16 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K050543.
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/K060625 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060625: Nexus Detachable Coil System, Morpheus 3D CSR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060625
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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