510(k) · Cleared
ClearedConcerto Detachable Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Feb 27, 2009 as substantially equivalent to K081465 (Micro Therapeutics, Inc., 2008) and 1 other predicate after a 51-day review. Its family tree reaches back 12 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 27, 2009
- Review
- 51 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K951256 (1995). 60 ancestors in all, the oldest K860840 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 8 generations between
- 3 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 2 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 1 generation backK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- This deviceK090046 Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK202850 Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
- Descendant · 2 generations on · 1 of its ownK253511 Concerto Versa™ Detachable CoilMedtronic, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK261866 Concerto Versa™ Detachable CoilMedtronic, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 10 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 8 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 7 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 6 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 5 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 4 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 3 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 2 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 1 generation backK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- This deviceK090046 Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · cites it directly2descendants
- K253511Concerto Versa™ Detachable CoilMedtronic, Inc. · 2026 · 2 generations on1descendant
- K261866Concerto Versa™ Detachable CoilMedtronic, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −11 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −10 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −8 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −7 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −6 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −5 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| −4 | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | 1 |
| −3 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| −2 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| −1 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| 0 (this device) | K090046 | Concerto Detachable Coil System | Micro Therapeutics, Inc. | 2009 | — |
| +1 | K202850 | Concerto Versa, Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021 | — |
| +2 | K253511 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026 | — |
| +3 | K261866 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K081465 | Axium Detachable Coil SystemSummary page 1…Class II Predicate Devices: Micro Therapeutics, Inc. AxiumTM Detachable Coil System clearedunder K081465 on Aug 19, 2008; Micro Therapeutics, Inc. FX Detachable Coil System… | 2008 |
| * | K060747 | FX Detachable Coil SystemSummary page 1…er K081465 on Aug 19, 2008; Micro Therapeutics, Inc. FX Detachable Coil System clearedunder K060747 on April 24, 2007 - marketed as the ev3® AxiumTM Detachable Coil System Manufacturer:… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202850 | Concerto Versa, Detachable Coil | 2021 | 2 |
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 5 companies; a new generation was cleared every 10 months on median.
- 9 of the 60 ancestors have a recall of any class.
- Of its descendants, K202850 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K081465.
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. 2009, 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 ConcertoTM Detachable Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090046: Concerto 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/K090046
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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