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 Dec 2, 2014 as substantially equivalent to K123696 (Endoshape, Inc., 2013) after a 246-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Dec 2, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K891688 (1989). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 6 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 5 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 4 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- 3 generations backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- 2 generations backK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
- 1 generation backK123696 Medusa Vascular PlugEndoshape, Inc. · 2013
- This deviceK140796 Medusa Vascular Plug,Endoshape, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −6 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −5 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −4 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| −3 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| −2 | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | 1 |
| −1 | K123696 | Medusa Vascular Plug | Endoshape, Inc. | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K123696 | Medusa Vascular PlugSummary page 4…lar Plug Generic/Common Name: Vascular Embolization Device Classification: 21 CFR§870.3300, Class II Product Code: KRD PREDICATE DEVICE Medusa™ Vascular Plug (K123696) INDICATIONS FOR USE The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the periphera… | 2013 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 16 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. 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 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/K140796 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140796: Medusa Vascular Plug,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140796
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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