510(k) · Cleared
ClearedBiomerix Vascular Occlusion Device and Loader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerix Corporation · KRD Device, Vascular, For Promoting Embolization
Cleared on Feb 3, 2005 as substantially equivalent to K031810 (Aga Medical Corp., 2003) after a 57-day review. Its family tree reaches back 6 generations to 1989. 20 later devices descend from it.
- Decided
- Feb 3, 2005
- Review
- 57 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K891688 (1989). 15 ancestors in all. 20 later devices descend from it, 2 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 deviceK043371 Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation · 2005
- Descendant · cites it directly · 17 of its ownK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- Descendant · 2 generations on · 11 of its ownK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- Descendant · 3 generations on · 7 of its ownK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- Descendant · 4 generations on · 5 of its ownK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- Descendant · 5 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008 · cites it directly17descendants
- K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008 · 2 generations on11descendants
- K090288Orthadapt PRPegasus Biologics, Inc. · 2009 · 3 generations on7descendants
- K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011 · 4 generations on5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 5 generations on4descendants
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) | K043371 | Biomerix Vascular Occlusion Device and Loader | Biomerix Corporation | 2005 | — |
| +1 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| +2 | K072370 | Surgicraft Surgical Mesh System | Surgicraft, Ltd. | 2008 | — |
| +3 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| +4 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| +5 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K942189 | FDA’s K942189 is Crystal Ear Our reading of the summary gave K942189, FDA’s number for Crystal Ear (Crystal Care Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cook Embolization Coils”. Kept off the family tree. Summary page 1…ader Device Common Name: Arterial embolization device Classification Name: Device, embolization, arterial Predicate Devices: Cook Embolization Coils, K942189 Amplatzer ® Vascular Plug, K031810 Device Description: The Biomerix Vascular Occlusion Device is… | 1994 |
| * | K031810 | Amplatzer Vascular PlugSummary page 1…Classification Name: Device, embolization, arterial Predicate Devices: Cook Embolization Coils, K942189 Amplatzer ® Vascular Plug, K031810 Device Description: The Biomerix Vascular Occlusion Device is a cylindrical device made from pol… | 2003 |
What descends from it? (20)
See all 202 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 16 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K070961 (Biomerix Corporation, 2008) has gone furthest, with 17 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.
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 Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043371: Biomerix Vascular Occlusion Device and Loader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043371
Report an extraction error
Are you the manufacturer?
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