| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | 2025-02-13 |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. | 2025-01-31 |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC | 2025-01-15 |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. | 2024-12-20 |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-10-11 |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 |
| K232715 | Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. | 2024-05-31 |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | Hangzhou Aichek Medical Technology Co., Ltd. | 2024-04-12 |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | 2024-04-05 |
| K233174 | FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream | Assure Tech. (Hangzhou) Co, Ltd. | 2024-02-05 |
| K240025 | Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2024-01-31 |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | Nantong Egens Biotechnology Co., Ltd. | 2024-01-26 |
| K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2023-10-13 |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-02-28 |
| K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022-11-30 |
| K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-09-21 |
| K212418 | hCG One Step Pregnancy Test | Healstone Biotech, Inc. | 2022-06-30 |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream | Co-Innovation Biotech Co., Ltd. | 2022-04-05 |
| K210341 | One Step Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-03-10 |
| K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022-02-18 |
| K200913 | Clearblue® Early Digital Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2021-08-13 |
| K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) | Atlas Link Technology Co., Ltd. | 2021-08-04 |
| K193318 | Distinct® Early Detection Pregnancy Test | ACON Laboratories, Inc. | 2020-08-20 |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-08-13 |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream | Hangzhou Clongene Biotech Co., Ltd. | 2019-12-11 |
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | Innovita (Tangshan) Biological Technology Co., Ltd. | 2019-11-22 |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | Qingdao Hightop Biotech Co., Ltd. | 2019-09-05 |