Devices descending from K161216
23 later devices reach Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K181159 | LZI Fentanyl Enzyme Immunoassay | Lin-Zhi International, Inc. | 2018 | 2 | — |
| +1 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | 19 | — |
| +2 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 | Shenzhen Superbio Technology Co., Ltd. | 2022 | 17 | — |
| +2 | K201938 | LZI Fentanyl II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020 | 1 | — |
| +2 | K200197 | ARK Fentanyl II Assay | Ark Diagnostics, Inc. | 2020 | 0 | — |
| +3 | K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2025 | 0 | — |
| +3 | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | 2 | — |
| +3 | K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024 | 1 | — |
| +3 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | 11 | — |
| +4 | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative… | Healgen Scientific,, LLC | 2025 | 0 | — |
| +4 | K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®… | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | 0 | — |
| +4 | K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™… | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | 0 | — |
| +4 | K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024 | 0 | — |
| +4 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | 9 | — |
| +5 | K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | 2024 | 0 | — |
| +5 | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®… | Qingdao Hightop Biotech Co., Ltd. | 2024 | 1 | — |
| +5 | K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test… | Guangzhou Wondfo Biotech Co., Ltd. | 2024 | 0 | — |
| +5 | K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl… | Healgen Scientific,, LLC | 2024 | 0 | — |
| +5 | K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. | 2024 | 0 | — |
| +5 | K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. | 2024 | 0 | — |
| +5 | K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions | 2024 | 0 | — |
| +5 | K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | Assure Tech., LLC | 2024 | 0 | — |
| +6 | K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl… | Eterbio, Inc. | 2024 | 0 | — |