510(k) · Cleared
ClearedModification to Sapphire Detachable Coil System (Tetris 3-D)
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 Mar 25, 2004 after an 8-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 29 later devices descend from it.
- Decided
- Mar 25, 2004
- Review
- 8 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
29 later devices descend from it, 1 citing it directly.
- This deviceK040694 Modification to Sapphire Detachable Coil System (Tetris 3-D)Micro Therapeutics, Inc. · 2004
- Descendant · cites it directly · 28 of its ownK041649 Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004
- Descendant · 2 generations on · 27 of its ownK050543 Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005
- Descendant · 3 generations on · 24 of its ownK051560 Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
- Descendant · 3 generations on · 24 of its ownK051425 Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
- Descendant · 2 generations on · 23 of its ownK060747 FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K041649Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004 · cites it directly28descendants
- K050543Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005 · 2 generations on27descendants
- K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · 3 generations on24descendants
- K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005 · 3 generations on24descendants
- K060747FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040694 | Modification to Sapphire Detachable Coil System (Tetris 3-D) | Micro Therapeutics, Inc. | 2004 | — |
| +1 | K041649 | Sapphire NXT Detachable Coil System | Micro Therapeutics, Inc. | 2004 | — |
| +2 | K050543 | Nexus Detachable Coil System | Micro Therapeutics, Inc. | 2005 | — |
| +3 | K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR | Micro Therapeutics, Inc. | 2005 | — |
| +3 | K051425 | Nexus Detachable Coil System, Helix Super Soft CSR | Micro Therapeutics, Inc. | 2005 | — |
| +2 | K060747 | FX Detachable Coil System | Micro Therapeutics, Inc. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K913418 | FDA’s K913418 is Senographe DMR/SMR/DM Our reading of the summary gave K913418, FDA’s number for Senographe DMR/SMR/DM (General Electric Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sapphire Detachable Coil System”. Kept off the family tree. | 1992 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041649 | Sapphire NXT Detachable Coil System | 2004 | 28 |
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?
- Of its descendants, K041649 (Micro Therapeutics, Inc., 2004) has gone furthest, with 28 descendants of its own.
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 SapphireTM 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 Sapphire Tm 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/K040694 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040694: Modification to Sapphire Detachable Coil System (Tetris 3-D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040694
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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