510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)

K050954510(k) TraditionalCleared Jun 28, 200574-day reviewClass II21 CFR 882.5950Recalls 16

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 Jun 28, 2005 as substantially equivalent to K032590 (MicroVention, Inc., 2003) and 3 other predicates after a 74-day review. Its family tree reaches back 10 generations to 1995. 65 later devices descend from it. It has been recalled 16 times.

Decided
Jun 28, 2005
Review
74 days
Class
Class II
Product code
HCG
Recalls
16
Predicates
4

Its longest line of descent runs back 10 generations to K951256 (1995). 41 ancestors in all, the oldest K860840 (1986). 65 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 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: 11 descendants cleared2007: 1 descendant cleared2009: 7 descendants cleared2008: 3 descendants cleared2017: 2 descendants cleared2011: 5 descendants cleared2012: 5 descendants cleared2010: 4 descendants cleared2015: 4 descendants cleared2020: 3 descendants cleared2016: 3 descendants cleared2022: 5 descendants cleared2021: 1 descendant cleared2014: 4 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared2026: 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. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 7 other ancestors4 generations back: 18 other ancestors5 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 14 descendants3 generations forward: 17 descendants4 generations forward: 6 descendants5 generations forward: 9 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 2 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K041551 · 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+5+10
  1. Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
  2. 6 generations between
  3. 3 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  4. 2 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  5. 1 generation backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
  6. This deviceK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005
  7. Descendant · cites it directly · 36 of its ownK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
  8. Descendant · cites it directly · 35 of its ownK082461 Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008
  9. Descendant · 2 generations on · 34 of its ownK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
  10. Descendant · 2 generations on · 27 of its ownK090891 Microplex Coil System-CosmosMicroVention, Inc. · 2009 · Recalled
  11. Descendant · cites it directly · 23 of its ownK091641 Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System…MicroVention, Inc. · 2009 · Recalled
Show all 10 generations
  1. Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
  2. 9 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
  3. 8 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
  4. 7 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
  5. 6 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
  6. 5 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
  7. 4 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
  8. 3 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  9. 2 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
  10. 1 generation backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
  11. This deviceK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32009: 72010: 42011: 52012: 52013: 112014: 42015: 42016: 32017: 22018: 22019: 12020: 32021: 12022: 52024: 12025: 22026: 1
2007high 11 (2013) · low 0 (2023)2026

Most influential descendants

Showing 5 of 65 · See all
  • K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · cites it directly36descendants
  • K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008 · cites it directly35descendants
  • K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008 · 2 generations on34descendants
  • K090891Microplex Coil System-CosmosMicroVention, Inc. · 2009 · 2 generations on27descendants
  • K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc. · 2009 · cites it directly23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K951256Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics1995—
−9K960705Guglielmi Detachable CoilTarget Therapeutics1996—
−8K962503Guglielmi Detachable CoilTarget Therapeutics1996—
−7K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…Target Therapeutics1997—
−6K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999—
−5K012145Microplex Coil SystemMicroVention, Inc.2001—
−4K020434Microplex Coil System (MCS)MicroVention, Inc.2002—
−3K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2003—
−2K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.2003—
−1K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.2004—
0 (this device)K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.2005—
+1K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.2007—
+1K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.2008—
+2K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.2008—
+2K090891Microplex Coil System-CosmosMicroVention, Inc.20092
+1K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.20096

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
200970
201040
201150
201250
2013110
201440
201540
201630
201720
201820
201910
202030
202110
202250
202410
202520
202610
FIG. 1 — Lineage of K050954, 1995–2026Source: 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? (4)

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
*K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)
Summary page 2
…ined to be substantially equivalent on October 22, 2003 (10) Coils (reference K032590), the HydroCoil® Embolic System (HES) with HES-HC-S that was determined to be substantially equivalent on December 30, 2003…
MicroVention, Inc.2003—
*K033836Hydrocoil Embolic System (Hes)
Summary page 2
…(reference K032590), the HydroCoil® Embolic System (HES) with HES-HC-S that was determined to be substantially equivalent on December 30, 2003 (reference K033836), the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on July 7, 2004 (reference K041551…
MicroVention, Inc.2003—
*K041551Modification to: Hydrocoil Embolic System (Hes)
Summary page 2
…t on December 30, 2003 (reference K033836), the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on July 7, 2004 (reference K041551) and the Micrus MicroCoil System that was determined to be substantially equivalent on August 1, 2003 (reference K0…
MicroVention, Inc.2004—
*K031578Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR
Summary page 2
…ivalent on July 7, 2004 (reference K041551) and the Micrus MicroCoil System that was determined to be substantially equivalent on August 1, 2003 (reference K031578). (7) Technological Characteristics and Substantial Equivalence…
Micrus Corp.2003—

Also cleared against K032590: 3 other devices →

What descends from it? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736
K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835
K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.200923
K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823
K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918
K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095
K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172
K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131
K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 22, 2019Class IIZ-1403-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1404-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1399-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1407-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1405-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1394-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1400-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1401-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1402-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1406-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1393-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1392-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1396-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1397-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1395-2020Process designThe devices may be missing the implant coil.
Nov 22, 2019Class IIZ-1398-2020Process designThe devices may be missing the implant coil.

The 5 latest of 16 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 10 months on median.
  • 7 of the 41 ancestors have a recall of any class.
  • Of its descendants, K070656 (MicroVention, Inc., 2007) has gone furthest, with 36 descendants of its own.
  • 3 other devices also cite its predicate K032590.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The MicroPlex® Coil System (MCS) and HydroCoir Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The MCS and HES are 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 embolizations in the peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K032590

3 other devices cite the same predicate.

  • K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
  • K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
  • K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003

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/K050954 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050954

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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