510(k) · Cleared
ClearedSapphire NXT 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 Jul 16, 2004 as substantially equivalent to K030392 (Micro Therapeutics, Inc., 2003) and 2 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1990. 28 later devices descend from it.
- Decided
- Jul 16, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K901337 (1990). 5 ancestors in all. 28 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK901337 Hilal Embolization Microcoil (TM)Cook, Inc. · 1990 · Recalled
- 1 generation backK033372 Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone…Micro Therapeutics, Inc. · 2004
- This deviceK041649 Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004
- Descendant · cites it directly · 27 of its ownK050543 Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005
- Descendant · 2 generations on · 24 of its ownK051560 Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
- Descendant · 2 generations on · 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
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K050543Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005 · cites it directly27descendants
- K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · 2 generations on24descendants
- K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · 2 generations on24descendants
- K060747FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007 · cites it directly23descendants
- K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901337 | Hilal Embolization Microcoil (TM) | Cook, Inc. | 1990 | 2 |
| −1 | K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models | Micro Therapeutics, Inc. | 2004 | — |
| 0 (this device) | K041649 | Sapphire NXT Detachable Coil System | Micro Therapeutics, Inc. | 2004 | — |
| +1 | K050543 | Nexus Detachable Coil System | Micro Therapeutics, Inc. | 2005 | — |
| +2 | K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR | Micro Therapeutics, Inc. | 2005 | — |
| +2 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K030392 | Sapphire Detachable Coil SystemSummary page 1…r Description Predicate For Clearance Date K030392 Sapphire Detachable Coil Sapphire NXT Detachable Coil July 21, 2003 System… | 2003 |
| * | K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple ModelsSummary page 1…Date K030392 Sapphire Detachable Coil Sapphire NXT Detachable Coil July 21, 2003 System System K033372 Sapphire Detachable Sapphire NXT Detachable January 9, 2004 Fibered Coil System… | 2004 |
| * | K040694 | Modification to Sapphire Detachable Coil System (Tetris 3-D)Summary page 1…m K033372 Sapphire Detachable Sapphire NXT Detachable January 9, 2004 Fibered Coil System Fibered Coil System K040694 Sapphire Tetris 3D Sapphire NXT Tetris 3D March 25, 2004 Detachable Coil Syste… | 2004 |
What descends from it? (28)
See all 282 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 14 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K050543 (Micro Therapeutics, Inc., 2005) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K030392.
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 Sapphire TM 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 SapphireTM 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/K041649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041649: Sapphire NXT Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041649
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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