510(k) · Cleared
Recalled · Class II · 2019Azur Detachable 18
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Mar 28, 2012 as substantially equivalent to K090168 (MicroVention, Inc., 2009) and 1 other predicate after a 27-day review. Its family tree reaches back 12 generations to 1995. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 28, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- KRD
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 12 generations to K951256 (1995). 50 ancestors in all, the oldest K860840 (1986). 4 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 backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 2 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 1 generation backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- This deviceK120630 Azur Detachable 18MicroVention, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK123384 Azur CX Detachable 18MicroVention, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK162524 AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK223050 AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035…MicroVention, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK151358 AZUR CX Detachable 35 CoilsMicroVention, Inc. · 2015 · Recalled
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 backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 7 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 6 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 5 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 4 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 3 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 2 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 1 generation backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- This deviceK120630 Azur Detachable 18MicroVention, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K123384Azur CX Detachable 18MicroVention, Inc. · 2012 · cites it directly3descendants
- K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc. · 2017 · 2 generations on1descendant
- K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc. · 2022 · 2 generations on0descendants
- K151358AZUR CX Detachable 35 CoilsMicroVention, Inc. · 2015 · 2 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 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −7 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −6 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −5 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −4 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −3 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −2 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −1 | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
| 0 (this device) | K120630 | Azur Detachable 18 | MicroVention, Inc. | 2012 | — |
| +1 | K123384 | Azur CX Detachable 18 | MicroVention, Inc. | 2012 | — |
| +2 | K162524 | AZUR CX Detachable 18 Peripheral Coil System | MicroVention, Inc. | 2017 | — |
| +2 | K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050… | MicroVention, Inc. | 2022 | — |
| +2 | K151358 | AZUR CX Detachable 35 Coils | MicroVention, Inc. | 2015 | 4 |
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 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K090168 | Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415Summary page 1…Tustin, California U.S.A. Contact: Cynthia Valenzuela Predicate Device: Number Description Clearance Date K090168 AZUTR Peripheral HydraCoil March 12, 2009 Endovascular Embolization System -… | 2009 |
| * | K071939 | Hydrocoil Embolic Systems (Hes)Summary page 1…K090168 AZUTR Peripheral HydraCoil March 12, 2009 Endovascular Embolization System - Detachable 18 K071939 AZUR Peripheral HydraCoil January 11, 2008 Endovascular Embolization System -… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123384 | Azur CX Detachable 18 | 2012 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2019 | Class II | Z-1220-2020 | Other | The devices may be missing the implant coil. |
| Nov 24, 2019 | Class II | Z-1221-2020 | Other | The devices may be missing the implant coil. |
| Nov 24, 2019 | Class II | Z-1222-2020 | Other | The devices may be missing the implant coil. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 8 of the 50 ancestors have a recall of any class.
- Of its descendants, K123384 (MicroVention, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K090168.
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. 2012, 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 AZUR System is intended to reduce or block the rate of bloodflow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fisulae, aneurysms, and other lesions of the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120630 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120630: Azur Detachable 18.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120630
Report an extraction error
Are you the manufacturer?
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