510(k) · Cleared
ClearedReverse Medical Micro Vascular Plug System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reverse Medical Corporation · KRD Device, Vascular, For Promoting Embolization
Cleared on Jun 18, 2014 as substantially equivalent to K123803 (Reverse Medical Corporation, 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 15 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 18, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K951256 (1995). 85 ancestors in all, the oldest K860840 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations between
- 3 generations backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- 2 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 1 generation backK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- This deviceK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- Descendant · cites it directly · 4 of its ownK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018
- Descendant · cites it directly · 0 of its ownK213200 Solus Gold Embolization DeviceArtio Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK191680 AZUR Vascular PlugMicroVention, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK182390 IMPEDE-FX Embolization PlugShape Memory Medical · 2019
Show all 15 generations
- Root · 15 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 14 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 13 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 12 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 11 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 10 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 9 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 8 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 7 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 6 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 5 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 4 generations backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- 3 generations backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- 2 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 1 generation backK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- This deviceK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
Most influential descendants
Showing 5 of 5 · See all- K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015 · cites it directly4descendants
- K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical · 2018 · 2 generations on1descendant
- K213200Solus Gold Embolization DeviceArtio Medical, Inc. · 2022 · cites it directly0descendants
- K191680AZUR Vascular PlugMicroVention, Inc. · 2020 · 2 generations on0descendants
- K182390IMPEDE-FX Embolization PlugShape Memory Medical · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −14 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −13 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −12 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −11 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −10 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −9 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −8 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −7 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −6 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −5 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −4 | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
| −3 | K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35… | MicroVention, Inc. | 2009 | — |
| −2 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| −1 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| 0 (this device) | K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2014 | — |
| +1 | K150108 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2015 | — |
| +2 | K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE… | Shape Memory Medical | 2018 | — |
| +1 | K213200 | Solus Gold Embolization Device | Artio Medical, Inc. | 2022 | — |
| +2 | K191680 | AZUR Vascular Plug | MicroVention, Inc. | 2020 | — |
| +3 | 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 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1994 | 5 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 9 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K123803 | Reverse Medical Micro Vascular Plug (MVP) SystemSummary page 1…ion Device Device Classification : Class 2 Regulation Number: 870.3300 (product code: KRD) Predicate Devices: Reverse Medical MVP-3 (K123803) and Reverse Medical MVP-5 (K133282) Purpose of Suhmission The purpose of this special 51… | 2013 |
| * | K133282 | Reverse Medical Micro Vascular Plug (MVP) SystemSummary page 1…ber: 870.3300 (product code: KRD) Predicate Devices: Reverse Medical MVP-3 (K123803) and Reverse Medical MVP-5 (K133282) Purpose of Suhmission The purpose of this special 510(k) submission is to obtain market clearance for two (2) modifica… | 2013 |
What descends from it? (5)
2 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 19 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 14 of the 85 ancestors have a recall of any class.
- Of its descendants, K150108 (Reverse Medical Corporation, 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K123803.
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. 2014, 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 Reverse Medical(R) Corporation MVP(R) Micro Vascular Plug System 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/K141313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141313: Reverse Medical Micro Vascular Plug System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141313
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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