510(k) · Cleared

Recalled · Class I · 2025

CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

K220040510(k) TraditionalCleared Jul 14, 2022190-day reviewClass II21 CFR 882.5950Recalls 1 (1 Class I)

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

Medos International SARL · HCG Device, Neurovascular Embolization

Cleared on Jul 14, 2022 as substantially equivalent to K150319 (Codman & Shurtleff, Inc., 2015) after a 190-day review. Its family tree reaches back 13 generations to 1995. 1 of the 55 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided: Jul 14, 2022
Review: 190 days
Class: Class II
Product code: HCG
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 13 generations to K951256 (1995). 54 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet. 1 of the 55 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 13 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
9 generations between
3 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
2 generations backK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
1 generation backK150319 Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT…Codman & Shurtleff, Inc. · 2015
This deviceK220040 CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform…Medos International SARL · 2022

Show all 13 generations

Root · 13 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
12 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
11 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
10 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
9 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
8 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
7 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
6 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
5 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
4 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
3 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
2 generations backK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
1 generation backK150319 Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT…Codman & Shurtleff, Inc. · 2015
This deviceK220040 CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform…Medos International SARL · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−13	K951256	Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)	Target Therapeutics	1995	—
−12	K960705	Guglielmi Detachable Coil	Target Therapeutics	1996	—
−11	K962503	Guglielmi Detachable Coil	Target Therapeutics	1996	—
−10	K971395	Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…	Target Therapeutics	1997	—
−9	K993415	GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch…	Boston Scientific, Target	2000	—
−8	K022420	Micrus Stretch-Resistant Microcoil System, MSR01	Micrus Corp.	2002	—
−7	K033813	Micrus Modified Microcoil System, Cerecyte	Micrus Corp.	2004	—
−6	K053160	Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che	Micrus Endovascular Corporation	2005	—
−5	K062036	Micrus Microcoil System Presidio-18, Model PC4	Micrus Endovascular Corporation	2006	1
−4	K070707	Micrus Microcoil System	Micrus Endovascular Corporation	2007	—
−3	K073442	Micrus Microcoil Systems	Micrus Endovascular Corporation	2008	—
−2	K082739	Micrus Microcoil Delivery System	Micrus Endovascular Corporation	2008	—
−1	K150319	Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch…	Codman & Shurtleff, Inc.	2015	—
0 (this device)	K220040	CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft…	Medos International SARL	2022	—

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	3	0
1995	2	0
1996	2	0
1997	2	0
1998	1	0
1999	2	0
2000	2	0
2001	2	0
2003	4	0
2004	1	0
2007	3	0
2008	2	0

FIG. 1 — Lineage of K220040, 1995–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K150319	Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant… Summary page 4 …Medos GALAXY G3, and GALAXY G3 XSFT Microcoil K150319 6/12/2015 International,…	Codman & Shurtleff, Inc.	2015	—
†	K171862	GALAXY G3 Mini Microcoil Delivery System	Codman & Shurtleff, Inc.	2017	1

Also cleared against K150319: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 2, 2025	Class I	Z-0434-2026	Under Investigation by firm	Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 11 months on median.
7 of the 54 ancestors have a recall of any class.
3 other devices also cite its predicate K150319.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · HCG

3in 2025

2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007high 173 (2018) · low 30 (2012)2026

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

Recalls per year · HCG

1in 2025

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

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

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 CEREPAKw Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems are indicated for embolization of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature.

The CEREPAKw Freeform XtraSoft Detachable Coil System is indicated for embolization of intracranial aneurysms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K220040 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220040: CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220040

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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