510(k) · Cleared
ClearedPenumbra Smart Coil
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 Mar 18, 2015 as substantially equivalent to K103305 (Penumbra, Inc., 2011) and 1 other predicate after a 128-day review. Its family tree reaches back 10 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 18, 2015
- Review
- 128 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K951256 (1995). 36 ancestors in all, the oldest K860840 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 6 generations between
- 3 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK103305 Penumbra Embolization Coil SystemPenumbra, Inc. · 2011 · Recalled
- 1 generation backK120330 Penumbra Coil System/Penumbra Coil 400Penumbra, Inc. · 2012
- This deviceK143218 Penumbra Smart CoilPenumbra, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK151572 Penumbra Smart CoilPenumbra, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK160832 Penumbra Smart CoilPenumbra, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK192955 Penumbra LP Coil SystemPenumbra, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK230284 Penumbra LP Coil SystemPenumbra, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 9 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 7 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 6 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 5 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 4 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 3 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK103305 Penumbra Embolization Coil SystemPenumbra, Inc. · 2011 · Recalled
- 1 generation backK120330 Penumbra Coil System/Penumbra Coil 400Penumbra, Inc. · 2012
- This deviceK143218 Penumbra Smart CoilPenumbra, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K151572Penumbra Smart CoilPenumbra, Inc. · 2015 · cites it directly3descendants
- K160832Penumbra Smart CoilPenumbra, Inc. · 2016 · cites it directly2descendants
- K192955Penumbra LP Coil SystemPenumbra, Inc. · 2019 · cites it directly1descendant
- K230284Penumbra LP Coil SystemPenumbra, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −9 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −7 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −6 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −5 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −4 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −3 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −2 | K103305 | Penumbra Embolization Coil System | Penumbra, Inc. | 2011 | 1 |
| −1 | K120330 | Penumbra Coil System/Penumbra Coil 400 | Penumbra, Inc. | 2012 | — |
| 0 (this device) | K143218 | Penumbra Smart Coil | Penumbra, Inc. | 2015 | — |
| +1 | K151572 | Penumbra Smart Coil | Penumbra, Inc. | 2015 | — |
| +1 | K160832 | Penumbra Smart Coil | Penumbra, Inc. | 2016 | — |
| +1 | K192955 | Penumbra LP Coil System | Penumbra, Inc. | 2019 | — |
| +2 | K230284 | Penumbra LP Coil System | Penumbra, Inc. | 2023 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K103305 | Penumbra Embolization Coil SystemSummary page 5…510(k) Number Clearance Date Name of Predicate Device Manufacturer K103305 January 26, 2011 Penumbra Coil System Penumbra, Inc. K120330 April 02, 2012… | 2011 |
| * | K120330 | Penumbra Coil System/Penumbra Coil 400Summary page 5…Manufacturer K103305 January 26, 2011 Penumbra Coil System Penumbra, Inc. K120330 April 02, 2012 Penumbra Coil System Penumbra, Inc. 11.8 Predicate Comparison… | 2012 |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 36 ancestors have a recall of any class.
- Of its descendants, K151572 (Penumbra, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K103305.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Smart Coil 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/K143218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143218: Penumbra Smart Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143218
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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