510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES | Geo Medical Co., Ltd | LPL | Class II | |
| K253682 | DeepHealth ProstateAI | Quantib B.V. | QDQ | Class II | |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular | MOF | Class II | |
| K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | OVD | Class II | |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | BZD | Class II | |
| K252542 | LEO Spinal System | Zhejiang Decans Medical Devices Co.,Ltd. | NKB | Class II | |
| K252471 | Paptizer 360 | Liviliti Health Products Corp | QXQ | Class II | |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | HONSUN (NANTONG) Co., Ltd. | DXN | Class II | |
| K260248 | Ultra-Fast Warm | Kitazato Corporation | MQL | Class II | |
| K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | MQG | Class II | |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | IOR | Class I | |
| K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems | PFW | Class II | |
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | Guangzhou Wondfo Biotech Co., Ltd. | NFT | Class II | |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International SA | NKB | Class II | |
| K253243 | Cardinal Health™ Poly Reinforced Surgical Gown | Medtronic, Inc. | FYA | Class II | |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) | Dolanvy (Suzhou) Medical Technology Co., Ltd | KPI | Class II | |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co, Ltd. | NBL | Class II | |
| K252424 | Anti-HCV Next | Abbott Medical | MZO | Class II | |
| K261357 | Grandio disc multicolor | Voco GmbH | EBF | Class II | |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF | Class II | |
| K261032 | NovoKnee (SteriKnee) | Novosource, LLC | JWH | Class II | |
| K260660 | SABER-C System | Elevation Spine | OVE | Class II | |
| K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | Zimmer GmbH | LZO | Class II | |
| K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | JPA | Class II | |
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | HIR | Class II | |
| K252628 | Cassie | Wesper, Inc. | MNR | Class II | |
| K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular LLC | DSY | Class II | |
| K252409 | TearCare MGX System | Sight Sciences, Inc. | ORZ | Class II | |
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations, Inc. | PDQ | Class II | |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | HSB | Class II | |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | Howmedica Osteonics Corp | MQV | Class II | |
| K260999 | LoFric Elle Pro | Wellspect Inc. | EZD | Class II | |
| K260993 | Amplatzer TorqVue Delivery System | Abbott Medical | DQY | Class II | |
| K260988 | °M Warmer System with °M Station | Mequ A/S | LGZ | Class II | |
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | Applied Medical Resources Corp | KGW | Class II | |
| K260599 | INDIGO® Aspiration System – INDIGO Link | Penumbra Inc. | QEW | Class II | |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab Inc | ODP | Class II | |
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | QJI | Class II | |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | HRS | Class II | |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | HRS | Class II | |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | HRS | Class II | |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical Inc | LLZ | Class II | |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | FGE | Class II | |
| K253805 | Knee+ | Pixee Medical S.A.S. | SBF | Class II | |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | Abbott Medical | NQQ | Class II | |
| K252810 | FloPatch FP120 | Flosonics Medical | DPW | Class II | |
| K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | SHU | Class II |