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 |
|---|---|---|---|---|---|
| K231086 | CPM System | Analog Devices | MWI | Class II | |
| K230439 | WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. | FER | Class II | |
| K230267 | NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. | QEP | Class II | |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | LZO | Class II | |
| DEN230020 | BioTraceIO Lite | Techsomed Medical Technologies, Ltd. | QZL | Class II | |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | KNF | Class II | |
| K233813 | Bearing nsPVA Express™ | Merit Medical Systems, Inc. | NAJ | Class II | |
| K233741 | Hoffmann LRF System | Stryker Corp. | KTT | Class II | |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., dba Stryker Orthopaedics | LPH | Class II | |
| K233465 | RadiForce MX317W | Eizo Corporation | PGY | Class II | |
| K233423 | Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System | Tyber Medical | HRS | Class II | |
| K233396 | Cannulated Screw System | Smith & Nephew, Inc. | HWC | Class II | |
| K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | DXQ | Class II | |
| K233154 | SkyOPS™ Orthopedic Plate System | Sky Surgical | HRS | Class II | |
| K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K233018 | PICOSECOND Nd:YAG Laser System | Ids, Ltd. | GEX | Class II | |
| K233016 | Dental Glass Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | EIH | Class II | |
| K232944 | CALLISTO eye | Carl Zeiss Meditec Inc | NFJ | Class II | |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | ETN | Class II | |
| K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | Varian Medical Systems, Inc. | IYE | Class II | |
| K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | PLQ | Class II | |
| K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | LLZ | Class II | |
| K232579 | Twoplus Applicator | Hannah Life Technologies Pte, Ltd. | QYZ | Class II | |
| K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | Medivators (A Subsidiary of Steris Corporation) | ODC | Class II | |
| K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte. Ltd. | IYO | Class II | |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | IYO | Class II | |
| K231531 | Pediarity™ | Hinlab Inc. | DQA | Class II | |
| K231307 | Elos Accurate Customized Abutment | Elos MedTech Pinol a/S | NHA | Class II | |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.p.A. | MBF | Class II | |
| K231027 | KaiBiLi Extended ViralTrans | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | JSM | Class I | |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K223729 | FLOWpresso | Medella Health Ltd | IRP | Class II | |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K221753 | Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. | OXZ | Class II | |
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | ODP | Class II | |
| K233782 | SmoothSkin Pure Adapt (SSG3) | Cyden Limited | OHT | Class II | |
| K233492 | EMS Neck Massager | Xiamen Comfier Technology Co., Ltd. | NGX | Class II | |
| K233176 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K233130 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K233017 | TM Plating System | Tyber Medical | HRS | Class II | |
| K232992 | 10Therma | Tentech Inc. | GEI | Class II | |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Chemtron Biotech, Inc. | DJG | Class II | |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | KGO | Class I | |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | Ortho-Clinical Diagnostics, Inc. | PGI | Class II | |
| K232048 | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Abbott Medical | DXG | Class II | |
| K232017 | ARK Methotrexate II Assay | Ark Diagnostics Inc | LAO | Unclassified | |
| K231968 | Tactoset® Injectable Bone Substitute | Anika Therapeutics, Inc. | MQV | Class II | |
| K231780 | Perifit Care+ | X6 Innovations | HIR | Class II | |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd | MUH | Class II | |
| K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | LOD | Class II |