510(k) · Cleared
ClearedMedusa Vascular Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endoshape, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Oct 25, 2013 as substantially equivalent to K031810 (Aga Medical Corp., 2003) after a 326-day review. Its family tree reaches back 6 generations to 1989. 1 later device descends from it.
- Decided
- Oct 25, 2013
- Review
- 326 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K891688 (1989). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 5 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 4 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 3 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- 2 generations backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- 1 generation backK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
- This deviceK123696 Medusa Vascular PlugEndoshape, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK140796 Medusa Vascular Plug,Endoshape, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140796Medusa Vascular Plug,Endoshape, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −5 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −4 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −3 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| −2 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| −1 | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | 1 |
| 0 (this device) | K123696 | Medusa Vascular Plug | Endoshape, Inc. | 2013 | — |
| +1 | K140796 | Medusa Vascular Plug, | Endoshape, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K031810 | Amplatzer Vascular PlugSummary page 1…evice Classification: 21 CFR§870.3300, Class 11 Product Code: ERD PREDICATE DEVICE(S) * Cook Embolization Coils (Pre-Amendment) * Amplatzer Vascular Plug (K031810) PACE 11 ENDOSHAPE, INC.… | 2003 |
| * | — | Cook Embolization Coils (Pre-Amendment) Named without a submission number |
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 |
|---|---|---|---|
| K140796 | Medusa Vascular Plug, | 2014 | 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 24 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K140796 (Endoshape, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K031810.
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. 2013, 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 Medusa' Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained and experienced in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123696: Medusa Vascular Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123696
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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