510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10

K103758510(k) SpecialCleared Apr 28, 2011126-day reviewClass II21 CFR 882.5950Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

MicroVention, Inc. · HCG Device, Neurovascular Embolization

Cleared on Apr 28, 2011 as substantially equivalent to K093919 (MicroVention, Inc., 2010) and 1 other predicate after a 126-day review. Its family tree reaches back 14 generations to 1995. 7 later devices descend from it. It has been recalled once.

Decided
Apr 28, 2011
Review
126 days
Class
Class II
Product code
HCG
Recalls
1
Predicates
2

Its longest line of descent runs back 14 generations to K951256 (1995). 48 ancestors in all, the oldest K860840 (1986). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2003: 3 other ancestors2002: 2 other ancestors2000: 4 other ancestors1994: 3 other ancestors1992: 5 other ancestors1990: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1995: 2 other ancestors1991: 2 other ancestors1989: 1 other ancestor1988: 3 other ancestors1986: 1 other ancestor2013: 3 descendants cleared2016: 3 descendants cleared2011: 1 descendant clearedK951256 · Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) · Target Therapeutics · 1995×2: 2 generations cleared close together, K960705 (1996), K962503 (1996) K971395 · Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce · Target Therapeutics · 1997K991139 · Guglielmi Detachable (GDC) · Boston Scientific, Target · 1999K012145 · Microplex Coil System · MicroVention, Inc. · 2001K020434 · Microplex Coil System (MCS) · MicroVention, Inc. · 2002×2: 2 generations cleared close together, K032590 (2003), K033836 (2003) K041551 · Modification to: Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2004K050954 · Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2005 · recalledK070656 · Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2007K080666 · Hydrosoft and Hydrosoft Plus Embolization Coil Systems · MicroVention, Inc. · 2008K090357 · Hydroframe (Hes) · MicroVention, Inc. · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors4 generations back: 1 other ancestor5 generations back: 4 other ancestors6 generations back: 7 other ancestors7 generations back: 18 other ancestors8 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants K090357 · Hydroframe (Hes) · MicroVention, Inc. · 2009 · recalledK080666 · Hydrosoft and Hydrosoft Plus Embolization Coil Systems · MicroVention, Inc. · 2008K070656 · Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2007K050954 · Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2005 · recalledK041551 · Modification to: Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2004K033836 · Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2003K032590 · Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) · MicroVention, Inc. · 2003K020434 · Microplex Coil System (MCS) · MicroVention, Inc. · 2002K012145 · Microplex Coil System · MicroVention, Inc. · 2001K991139 · Guglielmi Detachable (GDC) · Boston Scientific, Target · 1999K971395 · Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce · Target Therapeutics · 1997K962503 · Guglielmi Detachable Coil · Target Therapeutics · 1996K960705 · Guglielmi Detachable Coil · Target Therapeutics · 1996K951256 · Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) · Target Therapeutics · 1995−10−50
  1. Root · 14 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
  2. 10 generations between
  3. 3 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
  4. 2 generations backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
  5. 1 generation backK090357 Hydroframe (Hes)MicroVention, Inc. · 2009 · Recalled
  6. This deviceK103758 Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc. · 2011
  7. Descendant · cites it directly · 4 of its ownK111451 Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V…MicroVention, Inc. · 2011
  8. Descendant · cites it directly · 2 of its ownK132952 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK153594 MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · Recalled
  10. Descendant · cites it directly · 1 of its ownK131948 Microplex Coil System (MCS)MicroVention, Inc. · 2013 · Recalled
  11. Descendant · cites it directly · 0 of its ownK161367 HydroCoil Embolic System (HES)MicroVention, Inc. · 2016 · Recalled
Show all 14 generations
  1. Root · 14 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
  2. 13 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
  3. 12 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
  4. 11 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
  5. 10 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
  6. 9 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
  7. 8 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
  8. 7 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  9. 6 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  10. 5 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
  11. 4 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
  12. 3 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
  13. 2 generations backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
  14. 1 generation backK090357 Hydroframe (Hes)MicroVention, Inc. · 2009 · Recalled
  15. This deviceK103758 Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc. · 2011

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12013: 32016: 3
2011high 3 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc. · 2011 · cites it directly4descendants
  • K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · cites it directly2descendants
  • K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · 2 generations on1descendant
  • K131948Microplex Coil System (MCS)MicroVention, Inc. · 2013 · cites it directly1descendant
  • K161367HydroCoil Embolic System (HES)MicroVention, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K951256Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics1995—
−13K960705Guglielmi Detachable CoilTarget Therapeutics1996—
−12K962503Guglielmi Detachable CoilTarget Therapeutics1996—
−11K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…Target Therapeutics1997—
−10K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999—
−9K012145Microplex Coil SystemMicroVention, Inc.2001—
−8K020434Microplex Coil System (MCS)MicroVention, Inc.2002—
−7K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2003—
−6K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.2003—
−5K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.2004—
−4K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.200516
−3K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.2007—
−2K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.2008—
−1K090357Hydroframe (Hes)MicroVention, Inc.20092
0 (this device)K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.2011—
+1K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V…MicroVention, Inc.2011—
+1K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.201316
+2K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.201616
+1K131948Microplex Coil System (MCS)MicroVention, Inc.201311
+1K161367HydroCoil Embolic System (HES)MicroVention, Inc.20164

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198830
198910
199010
199120
199250
199430
199520
199620
199710
200040
200110
200220
200330
200810
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201330
201630
FIG. 1 — Lineage of K103758, 1995–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
Summary page 1
…714-247-8000 Contact: Laraine Pangelina Date Prepared: April 20, 2011 Predicate Device: MicroPlex Coil System, Cosmos 10 (K093919) HydroCoil Embolic System, HydroFrame 10 (K090357) Indications for Use: Intended for the endl…
MicroVention, Inc.20101
*K090357Hydroframe (Hes)
Summary page 1
…April 20, 2011 Predicate Device: MicroPlex Coil System, Cosmos 10 (K093919) HydroCoil Embolic System, HydroFrame 10 (K090357) Indications for Use: Intended for the endlovascular embolization of intracranial aneurysms a…
MicroVention, Inc.20092

Also cleared against K093919: 2 other devices →

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114
K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.20132
K131948Microplex Coil System (MCS)MicroVention, Inc.20131
K161367HydroCoil Embolic System (HES)MicroVention, Inc.20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 22, 2019Class IIZ-1402-2020Process designThe 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 16 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 11 of the 48 ancestors have a recall of any class.
  • Of its descendants, K111451 (MicroVention, Inc., 2011) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K093919.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HCG

3in 2025

2007: 82008: 92009: 72010: 82011: 92012: 72013: 72014: 52015: 52016: 72017: 52018: 42019: 12020: 22021: 52022: 32023: 22024: 42025: 32026 (partial year): 4
2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007: 50 days median2008: 71 days median2009: 48 days median2010: 72 days median2011: 78 days median2012: 30 days median2013: 67 days median2014: 66 days median2015: 60 days median2016: 37 days median2017: 97 days median2018: 173 days median2021: 103 days median2022: 114 days median2024: 49 days median2025: 107 days median2026 (partial year): 30 days median
2007high 173 (2018) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HCG

1in 2025

2007: 12008: 32010: 22011: 12013: 22014: 42022: 22024: 12025: 1, 1 Class I2026 (partial year): 1
2007high 4 (2014) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HCG

537in 2025

2007: 3262008: 7302009: 8212010: 8512011: 8942012: 1,1462013: 1,1032014: 1,7292015: 1,5982016: 1,9912017: 2,4942018: 2,0582019: 1,7632020: 1,7542021: 2,2682022: 6632023: 5682024: 5522025: 537
2007high 2,494 (2017) · low 326 (2007)2025

MAUDE reports naming product code HCG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078501326
20089713730
20097480821
20108722851
20119781894
201273001,146
201376721,103
201456641,729
201556001,598
201673701,991
201759702,494
2018417302,058
20191—01,763
20202—01,754
2021510302,268
202231142663
20232—0568
20244491552
202531071 (1)537
20264301—

What is it indicated for?

Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K093919

2 other devices cite the same predicate.

  • K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 201316 recalls
  • K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V…MicroVention, Inc. · 2011

More from MicroVention, Inc.

136 FDA decisions under this applicant name. See the company

  • P170013/S013Intraluminal Support Device LVIS/LVIS Jr./LVIS EVOMicroVention, Inc. · 2026
  • P210030/S002Roadsaver/CASPER Carotid Stent SystemMicroVention, Inc. · 2026
  • P170032/S022Woven EndoBridge (WEB) Aneurysm Embolization SystemMicroVention, Inc. · 2026
  • P170032/S021Woven EndoBridge (WEB) Aneurysm Embolization SystemMicroVention, Inc. · 2026
  • P170032/S019Woven EndoBridge Aneurysm Embolization (WEB) SystemMicroVention, Inc. · 2026

Recent decisions in HCG

The HCG category page

  • K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356)…Cerenovus, Inc. · 2026
  • K261772Target Xtra Detachable CoilStryker Neurovscular · 2026
  • K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
  • K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC · 2026
  • K252694Target Detachable CoilStryker Neurovascular · 2025

https://510kreport.com/device/K103758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103758: Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103758

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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