Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HCG — Predicate Candidate Screening
186 FDA 510(k) clearances under this product code; the 50 most recent screened below.
74 daysmedian FDA review time
194 days90th percentile
186clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261772 | Target Xtra Detachable Coil | Stryker Neurovscular | 2026-06-24 | 26 | 0 |
| K260351 | Numen™ Helia Coil Embolization System; NumenFR™ Detachment S | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026-05-20 | 106 | 0 |
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | 2026-01-27 | 29 | 0 |
| K252694 | Target Detachable Coil | Stryker Neurovascular | 2025-12-11 | 107 | 0 |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | 2025-10-17 | 123 | 0 |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | 2025-09-26 | 30 | 0 |
| K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-09-30 | 69 | 0 |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | 2024-09-27 | 28 | 0 |
| K242243 | Target Detachable Coils | Stryker Neurovscular | 2024-08-29 | 29 | 0 |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-01-10 | 111 | 0 |
| K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023-11-07 | 28 | 0 |
| K230284 | Penumbra LP Coil System | Penumbra, Inc. | 2023-10-25 | 265 | 0 |
| K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022-12-14 | 114 | 0 |
| K223386 | Optima Coil System | Balt USA, LLC | 2022-12-06 | 29 | 1 |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heli | Medos International SARL | 2022-07-14 | 190 | 1 |
| K212455 | InZone Detachment System | Stryker Neurovascular | 2021-11-16 | 103 | 1 |
| K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021-09-01 | 264 | 0 |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-07 | 226 | 0 |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT | Medos International SARL | 2021-05-28 | 25 | 0 |
| K210638 | i-ED COIL System | Kaneka Medical America, LLC | 2021-03-26 | 23 | 0 |
| K192068 | i-ED COIL | Kaneka Pharma America, LLC | 2020-04-25 | 268 | 0 |
| K200030 | Optima Coil System | Balt USA, LLC | 2020-02-01 | 25 | 3 |
| K192955 | Penumbra LP Coil System | Penumbra, Inc. | 2019-11-20 | 30 | 0 |
| K180653 | Spartan eCoil System | Spartan Micro, Inc. | 2018-12-04 | 266 | 0 |
| K173711 | Wallaby Avenir Coil System | Wallaby Medical, Inc. | 2018-05-04 | 151 | 0 |
| K173614 | Penumbra Coil 400, Ruby Coil System, POD System | Penumbra, Inc. | 2018-04-17 | 146 | 0 |
| K172390 | Optima Coil System | Blockade Medical, LLC (D.B.A. Balt Usa) | 2018-02-18 | 194 | 3 |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | Codman & Shurtleff, Inc. | 2017-09-25 | 95 | 0 |
| K170852 | POD Packing Coil | Penumbra, Inc. | 2017-07-19 | 119 | 0 |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, | Codman & Shurtleff, Inc. | 2017-07-14 | 31 | 0 |
| K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic | MicroVention, Inc. | 2017-03-29 | 152 | 0 |
| K162704 | Axium Prime Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-01-03 | 97 | 0 |
| K161367 | HydroCoil Embolic System (HES) | MicroVention, Inc. | 2016-08-31 | 106 | 0 |
| K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | MicroVention, Inc. | 2016-08-31 | 97 | 0 |
| K161429 | Target Detachable Coils | Stryker Neurovascular | 2016-06-22 | 30 | 0 |
| K153658 | Target Detachable Coils | Stryker Neurovascular | 2016-05-19 | 150 | 28 |
| K160832 | Penumbra Smart Coil | Penumbra, Inc. | 2016-04-20 | 26 | 0 |
| K160096 | InZone Detachment System | Stryker Neurovascular | 2016-02-19 | 31 | 0 |
| K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | MicroVention, Inc. | 2016-01-22 | 37 | 0 |
| K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-07-28 | 60 | 0 |
| K151760 | Barricade Embolization Coil System | Blockade Medical | 2015-07-27 | 28 | 0 |
| K151572 | Penumbra Smart Coil | Penumbra, Inc. | 2015-07-10 | 29 | 0 |
| K150319 | MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FIL | Codman & Shurtleff, Inc. | 2015-06-12 | 123 | 0 |
| K143218 | Penumbra Smart Coil | Penumbra, Inc. | 2015-03-18 | 128 | 0 |
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delive | Codman & Shurtleff, Inc. | 2014-12-24 | 117 | 0 |
| K142513 | Barricade Embolization Coil System | Blockade Medical | 2014-11-13 | 66 | 0 |
| K141134 | POD SYSTEM | Penumbra, Inc. | 2014-07-03 | 63 | 0 |
| K140104 | BARRICADE EMBOLIZATION COIL SYSTEM | Blockade Medical | 2014-02-13 | 29 | 0 |
| K133310 | AXIUM DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-01-10 | 74 | 0 |
| K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2013-12-19 | 91 | 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