Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HGX — Predicate Candidate Screening
248 FDA 510(k) clearances under this product code; the 50 most recent screened below.
145 daysmedian FDA review time
309 days90th percentile
248clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260259 | DiscreetDuo™ Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | 2026-07-24 | 177 | 0 |
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | 2026-07-13 | 91 | 0 |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | 2026-06-26 | 532 | 0 |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | 2026-06-25 | 87 | 0 |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-18 | 171 | 0 |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-17 | 120 | 0 |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH8 | Polybell (Guangzhou) Limited | 2026-06-12 | 129 | 0 |
| K250129 | AViTA Breast Pump | Avita Corporation | 2026-06-11 | 510 | 0 |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | 2026-06-09 | 84 | 0 |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | 2026-06-04 | 73 | 0 |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003 | Anker Innovations Limited | 2026-05-29 | 149 | 0 |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | 2026-05-21 | 143 | 0 |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026-05-13 | 145 | 0 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 | 142 | 0 |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2026-04-22 | 86 | 0 |
| K253510 | Freestyle Mini Hands-free | Medela, LLC | 2026-04-10 | 156 | 0 |
| K260033 | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | 2026-04-08 | 92 | 0 |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-08 | 100 | 0 |
| K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-07 | 118 | 0 |
| K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | 2026-04-06 | 437 | 0 |
| K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 72 | Cixi Ruihong Electric Appliance Co., Ltd. | 2026-04-03 | 217 | 0 |
| K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric b | A Cute Baby, Inc. | 2026-03-12 | 209 | 0 |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-03-09 | 90 | 0 |
| K253149 | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | 2026-02-13 | 141 | 0 |
| K252422 | Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 | 196 | 0 |
| K252420 | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 | 196 | 0 |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | 2026-02-06 | 274 | 0 |
| K253498 | Pump In Style® Pro+ | Medela, LLC | 2026-01-22 | 85 | 0 |
| K253072 | Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | 2025-12-23 | 91 | 0 |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 | 144 | 0 |
| K252754 | Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 | 112 | 0 |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | 2025-11-25 | 154 | 0 |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, | Shenzhen Root Innovation Technology Co., Ltd. | 2025-10-29 | 30 | 0 |
| K252629 | Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 | 68 | 0 |
| K252630 | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 | 68 | 0 |
| K251977 | electric breast pump (FZ-P8); electric breast pump (YH-P8); | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-10-22 | 117 | 0 |
| K251512 | Hi bebe super (BT-150B) | Bistos Co., Ltd. | 2025-09-25 | 132 | 0 |
| K251377 | Magic InBra | Medela AG | 2025-09-18 | 139 | 0 |
| K251754 | Wearable Breast Pump (Model S33) | Shenzhen TPH Technology Co., Ltd. | 2025-09-08 | 91 | 0 |
| K251394 | Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-09-08 | 126 | 0 |
| K250383 | Wearable Breast Pump (Model W6) | Shenzhen TPH Technology Co., Ltd. | 2025-08-20 | 190 | 0 |
| K252192 | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2025-08-13 | 30 | 0 |
| K250207 | eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast P | Anker Innovations Limited | 2025-08-11 | 199 | 0 |
| K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Mo | Shenzhen TPH Technology Co., Ltd. | 2025-07-31 | 133 | 0 |
| K250350 | Thrive 2-in-1 Breast Pump (Model P3) | Shenzhen TPH Technology Co., Ltd. | 2025-07-15 | 158 | 0 |
| K250368 | Wearable Breast Pump (Model S21) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 | 109 | 0 |
| K250365 | Motif Aura Glow breast pump (Model Motif Aura Glow) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 | 109 | 0 |
| K242725 | Youha electric breast pumps (The INs, The INs Gen2, The INs | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-05-30 | 262 | 0 |
| K243508 | Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. | 2025-04-21 | 160 | 0 |
| K250829 | Lacevo Wearable Breast Pump (Model S70) | Shenzhen TPH Technology Co., Ltd. | 2025-04-17 | 29 | 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