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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K161034 | Microcyn Plus Wound Care Solution | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K160366 | Electrosurgical disposable grounding pads | Top-rank Health Care Co.,Ltd. | ODR | Class II | |
| K160329 | InMode System MiniFX Handpiece | Inmode MD, Ltd. | PBX | Class II | |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Teleflex Medical | CCT | Class II | |
| K153364 | Kerecis SecureMesh | Kerecis Limited | OXE | Class II | |
| K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit | Cerenovus, Inc. | GWM | Class II | |
| K153286 | iHealth Align Gluco-Monitoring system | Andon Health Co., Ltd | NBW | Class II | |
| K153278 | Wireless Smart Gluco-Monitoring System | Andon Health Co., Ltd | NBW | Class II | |
| K162052 | Sentinella 102, Sentinella 102 Horus | General Equipment for Medical Imaging (Oncovision | IYX | Class I | |
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | KRA | Class II | |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | OCC | Class II | |
| K161315 | Vein Clamps, Artery Clamps | Aros Surgical Instruments Corporation | DXC | Class II | |
| K161105 | Reprocessed Compression Garments | Medtronic, Inc. | JOW | Class II | |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set | C.R. Bard Inc | FPA | Class II | |
| K153397 | S-Wire Guidewire System | Concert Medical, LLC | DQX | Class II | |
| K152390 | Medke Oximetry Finger Sensor | Shenzhen Medke Technology Co., Ltd. | DQA | Class II | |
| K152091 | Fingertip Pulse Oximeter | Jiangsu Konsung Bio-Medical Science and Technology Co Ltd | DQA | Class II | |
| K161748 | SUPRIA w/guideShot Option | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K161518 | Pacs Core/encore | Compania Mexicana de Radiologia CGR, S.A. de C.V. | LLZ | Class II | |
| K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | KXK | Class II | |
| K161385 | Just Like Me Personal Lubricant | Wtfn-Dba Classic Erotica/Holiday Products | NUC | Class II | |
| K161019 | Uroview FD | PAUSCH Medical GmbH | JAA | Class II | |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) | WHPM Inc. | DJR | Class II | |
| K160766 | Ambu USR, Ambu M | Ambu A/S | FAJ | Class II | |
| K160612 | Sumitomo Proton Therapy System | Sumitomo Heavy Industries, Ltd. | LHN | Class II | |
| K160075 | Accent XL | Alma Lasers Ltd. | IMI | Class II | |
| K160022 | LUOFUCON Silicone Ag foam dressing | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K152949 | WebPAX | Heart Imaging Technologies, LLC | LLZ | Class II | |
| K152289 | Alians Elbow Locking Plating System | Newclip Technics | HRS | Class II | |
| K152126 | Ust-5550-R; Ust-5536-R; L43k | Hitachi Aloka Medical America, Inc. | ITX | Class II | |
| K152089 | Wrist Pulse Oximeter | Jiangsu Konsung Bio-Medical Science and Technology Co Ltd | DQA | Class II | |
| K161933 | The Braun ThermoScan® 3 High Speed Compact Ear Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | |
| K161502 | MC1 Plus | General Project S.r.l. | IMI | Class II | |
| K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | Adapta Medical, Inc. | EZD | Class II | |
| K161403 | A.R.C. Laser Surgical Fibers and Probes | A.R.C. Laser GmbH | GEX | Class II | |
| K162196 | Dell UP3216Q with QUBYX PerfectLum bundle | Qubyx Software Technologies, Inc. | PGY | Class II | |
| K161292 | Distal Radius Plating System | Miami Device Solutions, LLC | HRS | Class II | |
| K161182 | Solana Trichomonas Assay | Ortho-Clinical Diagnostics, Inc. | OUY | Class II | |
| K161171 | PressureWire X Guidewire | Abbott Medical | DXO | Class II | |
| K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Life Spine | HRS | Class II | |
| K153478 | Sydney IVF Gamete Buffer | William A. Cook Australia Pty, Ltd. | MQL | Class II | |
| K152125 | Oral Surgery System and Accessories | Bonart Co. Ltd. | DZI | Class II | |
| K161661 | Thermi RF Accessories | Thermi | GEI | Class II | |
| K161324 | Raycell Mk2 | Best Theratronics Ltd. | MOT | Unclassified | |
| K161269 | CELTRA Press | Dentsply Sirona Inc | EIH | Class II | |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | Medtronic Sofamor Danek | OUR | Class II | |
| K160840 | Ecg100+, Ecg200+ | Cardioline S.p.A. | DPS | Class II | |
| K160592 | Supercath 6 | Togo Medikit Co., Ltd. | FOZ | Class II |