510(k) · Cleared
ClearedMicrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR
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 Aug 1, 2003 as substantially equivalent to K022420 (Micrus Corp., 2002) after a 73-day review. Its family tree reaches back 6 generations to 1995. 1 of the 117 devices in its family, counting itself, has a Class I recall. 91 later devices descend from it.
- Decided
- Aug 1, 2003
- Review
- 73 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K951256 (1995). 25 ancestors in all, the oldest K860840 (1986). 91 later devices descend from it, 4 citing it directly. 1 of the 117 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 5 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 2 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 1 generation backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- This deviceK031578 Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp. · 2003
- Descendant · cites it directly · 68 of its ownK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · 2 generations on · 67 of its ownK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · 2 generations on · 66 of its ownK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- Descendant · cites it directly · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 36 of its ownK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
Showing 5 of 91 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 91 · See all- K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · cites it directly68descendants
- K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 2 generations on67descendants
- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · 2 generations on66descendants
- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · cites it directly65descendants
- K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · 2 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −5 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −2 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −1 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| 0 (this device) | K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR | Micrus Corp. | 2003 | — |
| +1 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +2 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +2 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| +1 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| +2 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 1 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (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; 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 | K0002056 | Micrus Microcoil Delivery System Number could not be read | |
| * | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01Summary page 5…ical Tests and Conclusions (Unchanged) The non-clinical tests performed on the Micrus MicroCoil System were reviewed in 5 1Ok numbers KO02056 and K022420. A summary of non-clinical tests and results are supplied here as a reference. Test… | 2002 |
What descends from it? (91)
See all 914 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | 2003 | 68 |
| K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | 2005 | 65 |
| K073442 | Micrus Microcoil Systems | 2008 | 31 |
| K071246 | Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC… | 2007 | 0 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K032590 (MicroVention, Inc., 2003) has gone furthest, with 68 descendants of its own.
- 3 other devices also cite its predicate K022420.
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?
Micrus MicroCoil Systems are intended for endovascular embolization of
intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031578: Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031578
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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