510(k) · Cleared
ClearedIMPEDE-FX Embolization Plug
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 May 23, 2019 as substantially equivalent to K181051 (Shape Memory Medical, 2018) after a 261-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- May 23, 2019
- Review
- 261 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K951256 (1995). 100 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 18 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 14 generations between
- 3 generations backK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- 2 generations backK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
- 1 generation backK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018
- This deviceK182390 IMPEDE-FX Embolization PlugShape Memory Medical · 2019
Show all 18 generations
- Root · 18 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 17 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 16 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 15 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 14 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 13 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 12 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 11 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 10 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 9 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 8 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 7 generations backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- 6 generations backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- 5 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 4 generations backK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 3 generations backK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- 2 generations backK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
- 1 generation backK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018
- This deviceK182390 IMPEDE-FX Embolization PlugShape Memory Medical · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −17 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −16 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −15 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −14 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −13 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −12 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −11 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −10 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −9 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −8 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −7 | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
| −6 | K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35… | MicroVention, Inc. | 2009 | — |
| −5 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| −4 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| −3 | K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2014 | — |
| −2 | K150108 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2015 | — |
| −1 | K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE… | Shape Memory Medical | 2018 | — |
| 0 (this device) | 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Summary page 4…tion Device Classification Name: Device, embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD PREDICATE DEVICE IMPEDE Embolization Plug (K181051) REFERENCE DEVICE Vascular Solutions Gel Block Embolization Pledgets (K113266) DEVICE DESCRIPTION The IMPEDE-FX Embolization Pl… | 2018 |
| † | K113266 | Gel-Block Embolization Pledgets | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 14 of the 100 ancestors have a recall of any class.
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. 2019, 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-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182390: IMPEDE-FX Embolization Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182390
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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