Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Obstetrics/Gynecology — Predicate Candidate Screening
4,608 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
139 daysmedian FDA review time
298 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | 2026-08-07 | 60 | 0 |
| K260259 | DiscreetDuo™ Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | 2026-07-24 | 177 | 0 |
| K253694 | Natural Cycles | Natural Cycles Nordic AB | 2026-07-17 | 238 | 0 |
| K261706 | Endomat Select (UP220) | KARL STORZ SE & CO. KG | 2026-07-16 | 55 | 0 |
| K253662 | LIXI (LXOSFM1) | Luwi, LLC | 2026-07-14 | 236 | 0 |
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | 2026-07-13 | 91 | 0 |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | 2026-07-09 | 90 | 0 |
| K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | 2026-07-06 | 28 | 0 |
| DEN250034 | Claria System | Claria Medical, Inc. | 2026-07-02 | 329 | 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 |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C | Weyo Surgical Technology , Ltd. | 2026-06-25 | 314 | 0 |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | 2026-06-22 | 189 | 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 |
| K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | 2026-06-17 | 260 | 0 |
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Doub | Gimbo Medical Technology Shenzhen Co., Ltd. | 2026-06-15 | 263 | 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 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Pe | PR Personal Care Laboratories | 2026-06-11 | 52 | 0 |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147 | Hathor Professional Skincare , Ltd. | 2026-06-09 | 270 | 0 |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | 2026-06-09 | 84 | 0 |
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | 2026-06-04 | 258 | 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 |
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | 2026-05-21 | 132 | 0 |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | 2026-05-21 | 143 | 0 |
| K253911 | Derma-2 | Neko Health AB | 2026-05-20 | 163 | 0 |
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | 2026-05-15 | 149 | 0 |
| K250781 | Embryo Predict | Alife Health | 2026-05-15 | 427 | 0 |
| K253642 | Jada System (Jada-2002) | Organon, LLC | 2026-05-15 | 177 | 0 |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026-05-13 | 145 | 0 |
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026-05-04 | 258 | 0 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 | 142 | 0 |
| K260248 | Ultra-Fast Warm | Kitazato Corporation | 2026-04-28 | 91 | 0 |
| K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | 2026-04-28 | 96 | 0 |
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 | 241 | 0 |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2026-04-22 | 86 | 0 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | 2026-04-16 | 118 | 0 |
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 | 265 | 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 |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Ac | Hudi Pharma Srl | 2026-04-01 | 89 | 0 |
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | 2026-03-30 | 264 | 0 |
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026-03-27 | 337 | 0 |
| K252005 | Livi Device | Liviwell, Inc. | 2026-03-20 | 266 | 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