| K251040 | guangzhou decheng biotechnology co | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P | September 9, 2025 |
| K251053 | hangzhou alltest biotech co | Shinetell PlusTM Digital Early Pregnancy Test | July 15, 2025 |
| K250117 | assure tech | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | February 13, 2025 |
| K242135 | nanjing synthgene medical technology co | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synth | January 31, 2025 |
| K243573 | assure tech | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Casse | January 15, 2025 |
| K241394 | andon health co | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | December 20, 2024 |
| K240242 | anhui deepblue medical technology co | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test | October 11, 2024 |
| K241978 | hangzhou alltest biotech co | Shinetell Digital Pregnancy Test | August 13, 2024 |
| K240643 | guangzhou decheng biotechnology co | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc | June 21, 2024 |
| K232715 | acon laboratories | Distinct® Digital Pregnancy Test | May 31, 2024 |
| K233624 | hangzhou aichek medical technology co | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG | April 12, 2024 |
| K234152 | aceso laboratories | ACESO Early Pregnancy Test | April 5, 2024 |
| K233174 | assure tech. (hangzhou) co | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | February 5, 2024 |
| K240025 | spd swiss precision diagnostics | Clearblue® Early Detection Pregnancy Test | January 31, 2024 |
| K232864 | nantong egens biotechnology co | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | January 26, 2024 |
| K230741 | jiangsu macro and micro-test med-tech co | Macro & Micro-Test HCG Pregnancy Test Midstream | October 13, 2023 |
| K230038 | guangzhou decheng biotechnology co | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | February 28, 2023 |
| K222305 | guangzhou decheng biotechnology co | MissLan Digital Pregnancy Rapid Test | November 30, 2022 |
| K213379 | spd swiss precision diagnostics | Clearblue ® Early Pregnancy Test | September 21, 2022 |
| K212418 | healstone biotech | hCG One Step Pregnancy Test | June 30, 2022 |