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 Apr 22, 2015 as substantially equivalent to K141313 (Reverse Medical Corporation, 2014) and 2 other predicates after a 92-day review. Its family tree reaches back 16 generations to 1995. 4 later devices descend from it.
- Decided
- Apr 22, 2015
- Review
- 92 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K951256 (1995). 86 ancestors in all, the oldest K860840 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 12 generations between
- 3 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 2 generations backK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 1 generation backK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- This deviceK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
- Descendant · cites it directly · 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 · cites it directly · 0 of its ownK191680 AZUR Vascular PlugMicroVention, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK182390 IMPEDE-FX Embolization PlugShape Memory Medical · 2019
Show all 16 generations
- Root · 16 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 15 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 14 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 13 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 12 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 11 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 10 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 9 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 8 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 7 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 6 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 5 generations backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- 4 generations backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- 3 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 2 generations backK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 1 generation backK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- This deviceK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical · 2018 · cites it directly1descendant
- K213200Solus Gold Embolization DeviceArtio Medical, Inc. · 2022 · cites it directly0descendants
- K191680AZUR Vascular PlugMicroVention, Inc. · 2020 · cites it directly0descendants
- K182390IMPEDE-FX Embolization PlugShape Memory Medical · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −15 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −14 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −13 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −12 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −11 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −10 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −9 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −8 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −7 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −6 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −5 | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
| −4 | K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35… | MicroVention, Inc. | 2009 | — |
| −3 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| −2 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| −1 | K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2014 | — |
| 0 (this device) | 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 | — |
| +1 | K213200 | Solus Gold Embolization Device | Artio Medical, Inc. | 2022 | — |
| +1 | K191680 | AZUR Vascular Plug | MicroVention, Inc. | 2020 | — |
| +2 | 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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K141313 | Reverse Medical Micro Vascular Plug SystemSummary page 4…he Food, Drug and Cosmetic Act for vascular embolization devices. Predicate The predicate device is the Reverse Medical Micro Vascular Plug (MVP-3Q and Device MVP-5Q), K141313, concurrence date June 18, 2014, The predicate device is also Micro Information Vascular Plug (MVP-3) K123803 concurrence date… | 2014 |
| * | K123803 | Reverse Medical Micro Vascular Plug (MVP) SystemSummary page 4…Medical Micro Vascular Plug (MVP-3Q and Device MVP-5Q), K141313, concurrence date June 18, 2014, The predicate device is also Micro Information Vascular Plug (MVP-3) K123803 concurrence date July 2, 2013 and also (MVP-5) K133282 concurrence date Nov. 27, 2013. Purpose The purpose of this special 510(k… | 2013 |
| * | K133282 | Reverse Medical Micro Vascular Plug (MVP) SystemSummary page 4…), K141313, concurrence date June 18, 2014, The predicate device is also Micro Information Vascular Plug (MVP-3) K123803 concurrence date July 2, 2013 and also (MVP-5) K133282 concurrence date Nov. 27, 2013. Purpose The purpose of this special 510(k) submission is to obtain market clearance for two (2)… | 2013 |
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 10 months on median.
- 14 of the 86 ancestors have a recall of any class.
- Of its descendants, K181051 (Shape Memory Medical, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K141313.
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. 2015, 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 Micro Vascular Plug (MVP-7, MVP-9) System is intended for use 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/K150108 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150108: Reverse Medical Micro Vascular Plug System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150108
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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