510(k) · Cleared
Recalled · 2011Penumbra Embolization Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · HCG Device, Neurovascular Embolization
Cleared on Jan 26, 2011 as substantially equivalent to K031049 (Boston Scientific, Target, 2003) and 1 other predicate after a 78-day review. Its family tree reaches back 8 generations to 1995. 10 later devices descend from it. It has been recalled once.
- Decided
- Jan 26, 2011
- Review
- 78 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K951256 (1995). 34 ancestors in all, the oldest K860840 (1986). 10 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 6 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 5 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 4 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 3 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 2 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 1 generation backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- This deviceK103305 Penumbra Embolization Coil SystemPenumbra, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK120330 Penumbra Coil System/Penumbra Coil 400Penumbra, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK143218 Penumbra Smart CoilPenumbra, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK151572 Penumbra Smart CoilPenumbra, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK160832 Penumbra Smart CoilPenumbra, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK192955 Penumbra LP Coil SystemPenumbra, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc. · 2012 · cites it directly9descendants
- K143218Penumbra Smart CoilPenumbra, Inc. · 2015 · cites it directly4descendants
- K151572Penumbra Smart CoilPenumbra, Inc. · 2015 · 2 generations on3descendants
- K160832Penumbra Smart CoilPenumbra, Inc. · 2016 · 2 generations on2descendants
- K192955Penumbra LP Coil SystemPenumbra, Inc. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −7 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −6 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −5 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −4 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −3 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −2 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −1 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| 0 (this device) | K103305 | Penumbra Embolization Coil System | Penumbra, Inc. | 2011 | — |
| +1 | K120330 | Penumbra Coil System/Penumbra Coil 400 | Penumbra, Inc. | 2012 | — |
| +1 | K143218 | Penumbra Smart Coil | Penumbra, Inc. | 2015 | — |
| +2 | K151572 | Penumbra Smart Coil | Penumbra, Inc. | 2015 | — |
| +2 | K160832 | Penumbra Smart Coil | Penumbra, Inc. | 2016 | — |
| +2 | K192955 | Penumbra LP Coil System | Penumbra, Inc. | 2019 | — |
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 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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.
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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031049 | Guglielmi Detachable Coil (GDC)Summary page 1…e of Manufacturer (Town, 510(k) Number Device State) Guglielmi Detachable Coil Boston Scienitific Neurovascular K031049& (GDCTM) Fremont, CA K093 142 Penumbra=§… | 2003 |
| * | K093142 | Target Detachable Coils and Inzone Detachment SystemSummary page 1…State) Guglielmi Detachable Coil Boston Scienitific Neurovascular K031049& (GDCTM) Fremont, CA K093 142 Penumbra=§ Penumbra Coil System 7.7… | 2010 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2011 | Not classified | Z-1906-2011 | Process change control | The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the 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 4 companies; a new generation was cleared every 12 months on median.
- 7 of the 34 ancestors have a recall of any class.
- Of its descendants, K120330 (Penumbra, Inc., 2012) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K031049.
How does its category compare?
All HCG devicesHCG 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
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 Penumbra Coil System is indicated for the embolization of:
Intracranial aneurysms
Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Arterial and venous embolizations in the peripheral vasculature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103305: Penumbra Embolization Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103305
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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