Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KRD — Predicate Candidate Screening
132 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
261 days90th percentile
132clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 | 330 | 0 |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026-07-24 | 79 | 0 |
| K261866 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-06-24 | 20 | 0 |
| K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | 2026-06-12 | 106 | 0 |
| K260508 | LOBO Vascular Occlusion System | Okami Medical, Inc. | 2026-04-10 | 52 | 0 |
| K253511 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-01-14 | 70 | 0 |
| K253677 | Tembo Embolic System | Instylla, Inc. | 2025-12-15 | 24 | 0 |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | Boston Scientific Corporation | 2025-10-30 | 30 | 0 |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | 2025-09-23 | 242 | 0 |
| K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | 2025-07-09 | 173 | 0 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | 2025-05-30 | 28 | 0 |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 2025-05-16 | 46 | 0 |
| K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | 2025-05-15 | 104 | 0 |
| K250079 | Ruby XL System | Penumbra, Inc. | 2025-03-14 | 60 | 0 |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025-01-17 | 136 | 0 |
| K240873 | TEMBO Embolic System | Instylla, Inc. | 2024-12-16 | 262 | 0 |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | 2024-10-16 | 30 | 0 |
| K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific | 2024-10-03 | 42 | 0 |
| K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024-05-30 | 253 | 0 |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP | Merit Medical Systems, Inc. | 2024-05-02 | 92 | 0 |
| K234123 | Easi-Vue® embolic microspheres System | Abk Biomedical, Inc. | 2024-02-13 | 47 | 0 |
| K231554 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2023-11-14 | 168 | 0 |
| K230706 | EMBOLD™ Soft Detachable Coil System | Boston Scientific Corporation | 2023-06-27 | 105 | 0 |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-88003 | MicroVention, Inc. | 2022-12-21 | 83 | 0 |
| K220567 | Easi-Vue embolic microspheres System | Abk Biomedical, Inc. | 2022-09-07 | 191 | 0 |
| K213385 | GEM | Obsidio, Inc. | 2022-07-01 | 261 | 1 |
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | Okami Medical | 2022-04-29 | 78 | 0 |
| K213398 | EMBOLD Fibered Detachable Coil System | Boston Scientific Corporation | 2022-04-12 | 176 | 0 |
| K220699 | Prestige Coil System | Bait USA, LLC | 2022-04-08 | 29 | 2 |
| K213200 | Solus Gold Embolization Device | Artio Medical, Inc. | 2022-03-21 | 173 | 0 |
| K212057 | Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion S | Artventive Medical Group, Inc. | 2022-03-01 | 243 | 0 |
| K212817 | Merit Siege Vascular Plug | Merit Medical System, Inc. | 2021-12-15 | 103 | 0 |
| K210562 | HRSpheres Narrow-Size Embolic Microspheres | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2021-10-01 | 218 | 0 |
| K202850 | Concerto Versa, Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-02-09 | 134 | 0 |
| K203025 | LOBO Vascular Occlusion System (model LOBO-5) | Okami Medical | 2020-11-05 | 34 | 0 |
| K191680 | AZUR Vascular Plug | MicroVention, Inc. | 2020-03-20 | 270 | 0 |
| K200083 | EMBA Hourglass Peripheral Embolization Device (PED) | Embolic Acceleration, LLC | 2020-02-14 | 30 | 0 |
| K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization | C.R. Bard, Inc. | 2020-02-04 | 239 | 0 |
| K192480 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | 2019-11-21 | 72 | 0 |
| K192083 | Okami Medical LOBO Vascular Occlusion System | Okami Medical | 2019-10-30 | 89 | 0 |
| K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019-08-06 | 270 | 0 |
| K183578 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | 2019-06-18 | 179 | 0 |
| K182390 | IMPEDE-FX Embolization Plug | Shape Memory Medical | 2019-05-23 | 261 | 0 |
| K182944 | Dr. Amplatz Micro Plug | Ka Medical, LLC | 2019-04-17 | 176 | 0 |
| K181021 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2018-09-27 | 163 | 0 |
| K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018-07-16 | 60 | 0 |
| K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm | Shape Memory Medical | 2018-06-22 | 63 | 0 |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (60 | Vascular Solutions, Inc. | 2018-01-19 | 29 | 0 |
| K171946 | Gel-Bead | Vascular Solutions, Inc. | 2017-10-25 | 118 | 0 |
| K172372 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2017-09-06 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda