510(k) · Cleared
ClearedIMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shape Memory Medical · KRD Device, Vascular, For Promoting Embolization
Cleared on Jun 22, 2018 as substantially equivalent to K113266 (Vascular Solutions, Inc., 2012) and 3 other predicates after a 63-day review. Its family tree reaches back 17 generations to 1995. 1 later device descends from it.
- Decided
- Jun 22, 2018
- Review
- 63 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K951256 (1995). 99 ancestors in all, the oldest K860840 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 13 generations between
- 3 generations backK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 2 generations backK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- 1 generation backK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
- This deviceK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018
- Descendant · cites it directly · 0 of its ownK182390 IMPEDE-FX Embolization PlugShape Memory Medical · 2019
Show all 17 generations
- Root · 17 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 16 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 15 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 14 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 13 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 12 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 11 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 10 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 9 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 8 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 7 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 6 generations backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- 5 generations backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- 4 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 3 generations backK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 2 generations backK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- 1 generation backK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
- This deviceK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018
Most influential descendants
Showing 1 of 1 · See all- K182390IMPEDE-FX Embolization PlugShape Memory Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −16 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −15 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −14 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −13 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −12 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −11 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −10 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −9 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −8 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −7 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −6 | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
| −5 | K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35… | MicroVention, Inc. | 2009 | — |
| −4 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| −3 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| −2 | K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2014 | — |
| −1 | K150108 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2015 | — |
| 0 (this device) | K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE… | Shape Memory Medical | 2018 | — |
| +1 | K182390 | IMPEDE-FX Embolization Plug | Shape Memory Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113266 | Gel-Block Embolization PledgetsSummary page 4…ame: Device, embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD PREDICATE DEVICES Vascular Solutions Gel-Block Embolization Pledgets (K113266) Reverse Medical Micro Vascular Plug System (K150108) Biomerix Vascular Occlusion Device and Loader (K043371) Amplatzer Vascular… | 2012 |
| * | K150108 | Reverse Medical Micro Vascular Plug SystemSummary page 4…Class II, 21 CFR 870.3300 Product Code: KRD PREDICATE DEVICES Vascular Solutions Gel-Block Embolization Pledgets (K113266) Reverse Medical Micro Vascular Plug System (K150108) Biomerix Vascular Occlusion Device and Loader (K043371) Amplatzer Vascular Plug 4 (K113658) DEVICE DESCRIPTION The IMPEDE Embo… | 2015 |
| * | K043371 | Biomerix Vascular Occlusion Device and LoaderSummary page 4…DEVICES Vascular Solutions Gel-Block Embolization Pledgets (K113266) Reverse Medical Micro Vascular Plug System (K150108) Biomerix Vascular Occlusion Device and Loader (K043371) Amplatzer Vascular Plug 4 (K113658) DEVICE DESCRIPTION The IMPEDE Embolization Plug is indicated to obstruct or reduce the rat… | 2005 |
| * | K113658 | Amplatzer Vascular Plug 4Summary page 4…k Embolization Pledgets (K113266) Reverse Medical Micro Vascular Plug System (K150108) Biomerix Vascular Occlusion Device and Loader (K043371) Amplatzer Vascular Plug 4 (K113658) DEVICE DESCRIPTION The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral va… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182390 | IMPEDE-FX Embolization Plug | 2019 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 14 of the 99 ancestors have a recall of any class.
- Of its descendants, K182390 (Shape Memory Medical, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K113266.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181051: IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181051
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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