510(k) · Cleared
ClearedMicrus Microcoil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micrus Corp. · HCG Device, Neurovascular Embolization
Cleared on Nov 28, 2003 as substantially equivalent to K002056 (Micrus Corp., 2001) after a 74-day review. Its family tree reaches back 1 generation to 2001. 1 of the 35 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.
- Decided
- Nov 28, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002056 (2001). 33 later devices descend from it, 2 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK002056 Micrus Microcoil Delivery System, MDS03Micrus Corp. · 2001
- This deviceK032872 Micrus Microcoil SystemMicrus Corp. · 2003
- Descendant · cites it directly · 32 of its ownK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- Descendant · 2 generations on · 31 of its ownK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- Descendant · 3 generations on · 22 of its ownK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 2 generations on · 7 of its ownK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…4 generations on · 2022
Most influential descendants
Showing 5 of 33 · See all- K070707Micrus Microcoil SystemMicrus Endovascular Corporation · 2007 · cites it directly32descendants
- K073442Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008 · 2 generations on31descendants
- K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · 3 generations on22descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 4 generations on10descendants
- K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002056 | Micrus Microcoil Delivery System, MDS03 | Micrus Corp. | 2001 | — |
| 0 (this device) | K032872 | Micrus Microcoil System | Micrus Corp. | 2003 | — |
| +1 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| +2 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| +3 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| +4 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +2 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 1 |
| 2023 | 1 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K002056 | Micrus Microcoil Delivery System, MDS03Summary page 1…bolization Regulation Number: 882.5950 Product Code: HCG Device Class: Ill C. Predicate Device 51OW K002056: Micrus Microcoil Delivery System, cleared on Jan 11, 2001 D. Device Description The current Micrus Spherica… | 2001 |
What descends from it? (33)
See all 332 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Micrus Microcoil System is intended for endovascular embolization of intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032872: Micrus Microcoil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032872
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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