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 |
|---|---|---|---|---|---|
| K232603 | CamAPS FX | Camdiab, Ltd. | QJI | Class II | |
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | OXF | Class II | |
| K241143 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise N.V. | QHE | Class II | |
| K241126 | OviTex PRS | Tela Bio, Inc. | FTM | Class II | |
| K241106 | Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | OHT | Class II | |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co.,Ltd. | NGL | Class II | |
| K241014 | Biomet Kirschner Wires (K-Wires) | Zimmer GmbH | HTY | Class II | |
| K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | OAP | Class II | |
| K240224 | Zenition 90 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K240199 | IntraOp Alignment System | Alphatec Spine, Inc. | OWB | Class II | |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | QSY | Unclassified | |
| K233884 | INUMI™ Flex Needle | Galvanize Therapeutics | OAB | Class II | |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences LLC | DXE | Class II | |
| K233819 | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences LLC | DXE | Class II | |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | DQO | Class II | |
| K233099 | Gladiator | Rohrer Aesthetics, Inc. | GEI | Class II | |
| K232740 | Paltop Short Implants | Paltop Advanced Dental Solutions Ltd | DZE | Class II | |
| K232655 | Bonvadis® | Stemcyte, Inc. | FRO | Unclassified | |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | Centers for Disease Control and Prevention | OZE | Class II | |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K240433 | ProSeal™ Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte., Ltd. | ONB | Class II | |
| K233543 | YSIO X.pree | Siemens Medical Solutions | KPR | Class II | |
| K233442 | troCarWash™ System | Biotex, Inc. | OCX | Class II | |
| K233336 | 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | Acula Technology Corp | PGY | Class II | |
| K232946 | Yumizen H2500 | Horiba Abx SAS | GKZ | Class II | |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab, Inc. | LLZ | Class II | |
| K232677 | Reia pessary | Reia, LLC | HHW | Class II | |
| DEN230068 | 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 | 3M Company | SBE | Class II | |
| K241276 | Vector™ Pedicle Screw System | Innovasis, Inc | NKB | Class II | |
| K241252 | Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. | LYZ | Class I | |
| K240772 | Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) | Hunan Ceramaster Material Technology Co., Ltd | EIH | Class II | |
| K240520 | Diode Laser Hair Removal System (SH-VD910) | Beijing Sea Heart International Science and Technologyco.Ltd | GEX | Class II | |
| K240511 | Dentis s-Clean SQ-SL Fixture | Dentis Co.,Ltd | DZE | Class II | |
| K240474 | Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd | GEX | Class II | |
| K233620 | MIM - Centiloid Scaling | MIM Software Inc | LLZ | Class II | |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences LLC | DXE | Class II | |
| K233341 | Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | Medtronic, Inc. | BTR | Class II | |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | ETD | Class II | |
| K223399 | AViTA Pulse Oximeter | Avita Corporation | DQA | Class II | |
| K241175 | MiRus MoRe Lumbar Plating System | Mirus, LLC | KWQ | Class II | |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing LLC | DRC | Class II | |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | KWQ | Class II | |
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co. Ltd. | ONF | Class II | |
| K233933 | CIRRUS™ HD-OCT Model 6000 | Carl Zeiss Meditec Inc | OBO | Class II | |
| K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | MUJ | Class II | |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | KWQ | Class II | |
| K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. | FRN | Class II | |
| K232525 | Yoni.Fit Bladder Support | Watkins-Conti Products, Inc | HHW | Class II | |
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | LKD | Class II |