510(k) · Cleared
Recalled · 2005Amplatzer Vascular Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aga Medical Corp. · KRD Device, Vascular, For Promoting Embolization
Cleared on Sep 9, 2003 as substantially equivalent to K940189 (Cook, Inc., 1994) and 5 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1989. 38 later devices descend from it. It has been recalled once.
- Decided
- Sep 9, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- KRD
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 5 generations to K891688 (1989). 14 ancestors in all. 38 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 4 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 3 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 2 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- 1 generation backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- This deviceK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003
- Descendant · cites it directly · 20 of its ownK043371 Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation · 2005
- Descendant · 2 generations on · 17 of its ownK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- Descendant · cites it directly · 16 of its ownK071125 Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008…Aga Medical Corp. · 2007
- Descendant · 2 generations on · 15 of its ownK071699 Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020…Aga Medical Corp. · 2007
- Descendant · 2 generations on · 13 of its ownK113658 Amplatzer Vascular Plug 4Aga Medical Corp. · 2012
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation · 2005 · cites it directly20descendants
- K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008 · 2 generations on17descendants
- K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…Aga Medical Corp. · 2007 · cites it directly16descendants
- K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp. · 2007 · 2 generations on15descendants
- K113658Amplatzer Vascular Plug 4Aga Medical Corp. · 2012 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −4 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −3 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −2 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| −1 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| 0 (this device) | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | — |
| +1 | K043371 | Biomerix Vascular Occlusion Device and Loader | Biomerix Corporation | 2005 | — |
| +2 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| +1 | K071125 | Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010… | Aga Medical Corp. | 2007 | — |
| +2 | K071699 | Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022 | Aga Medical Corp. | 2007 | — |
| +2 | K113658 | Amplatzer Vascular Plug 4 | Aga Medical Corp. | 2012 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K940189 | Coil Positioner SetSummary page 2…able 6- 1 for summary of Technological Characteristics. The Embolization Coil Positioner Set was reviewed as substantially equivalent under D.C. K940189 and is indicated for arterial and venous embolization. The device is constructed of stainless steel and synthetic fiber w… | 1994 |
| * | K993455 | Flipper Detachable Embolization CoilSummary page 2…mm. A push-button release mechanism is the method of deployment. The Flipper Detachable Coil was reviewed as substantially equivalent under D.C. K993455 and is indicated for arterial and venous embolization for the peripheral vasculature. The device is constructed of stainl… | 2000 |
| * | K955293 | Fibered Platinum Coil, .035 TypeSummary page 2…nterlocking threads between the coils and the delivery wire are unscrewed. The Fibered Platinum Coil was reviewed as substantially equivalent under D.C. K955293 and is indicated for arterial and venous embolization in the peripheral vasculature. The device is constructed of platinu… | 1996 |
| * | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Summary page 2…ved by a wire guide which pushes the coil out of the catheter. The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256, K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arterioven… | 1995 |
| * | K960705 | Guglielmi Detachable CoilSummary page 2…wire guide which pushes the coil out of the catheter. The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256, K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistu… | 1996 |
| * | K962503 | Guglielmi Detachable CoilSummary page 2…hich pushes the coil out of the catheter. The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256, K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and… | 1996 |
What descends from it? (38)
See all 384 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2005 | Not classified | Z-0127-06 | Other | Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K043371 (Biomerix Corporation, 2005) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K940189.
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.
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 AMPLATZER Vascular Plug is indicated for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031810: Amplatzer 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/K031810
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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