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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K014188 | New Prophy Powder | Dentsply Intl. | KOJ | Class II | |
| K014171 | Advance Unicondylar Knee System | Wrightmedicaltechnologyinc | HRY | Class II | |
| K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | HWC | Class II | |
| K014127 | Karma Discovery, Model Kp40 | Vestil Manufacturing Corp. | ITI | Class II | |
| K013867 | Xive Dental Implant System | Friadent GmbH | DZE | Class II | |
| K012788 | Vaporized Hydrogen Peroxide (Vhp) Sterilization of Unmwpe Components in the Cofield Total Shoulder System, the Neer II | Smith & Nephew, Inc. | KWS | Class II | |
| K012787 | Vaporized Hydrogen Peroxide (Vhp) Sterilization of Uhmwpe Components in the Reflection Actabular System (Acetabular Line | Smith & Nephew, Inc. | LPH | Class II | |
| K012778 | Vaporized Hydrogen Peroxide (Vhp) Sterilization of Uhmwpe Components in the Genesis Knee System, the Genesis II Knee Sys | Smith & Nephew, Inc. | JWH | Class II | |
| K012755 | Autodimer Assay Model # 1431 | Xtrana, Inc. | DAP | Class II | |
| K020451 | Comfort Wheelchairs | Comfort Orthopedic Co., Ltd. | IOR | Class I | |
| K020336 | Endoscopic Camera Mc404/c3 | World of Medicine Lemke GmbH | GCJ | Class II | |
| K020270 | Sopro 367D 3Ccd Full Digital Endoscopy Camera | Sopro | GCJ | Class II | |
| K020248 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Trimethoprim/sulfamethoxazole (0.25/4.75-64/1216 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020233 | Chase Cardiovascular Patch Kit | Chase Medical, Inc. | DXZ | Class II | |
| K020162 | Dried Gram-Positive Mic/combo Panels with Penicillin | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K020160 | Dried Gram-Positive Mic/combo Panels with Ampicillin | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K020142 | Microscan Synergies Plus | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020041 | Ialuset Hydrocolloid | Institut Biochimique SA (Ibsa) | FRO | Unclassified | |
| K014158 | Endoscopic Camera Tc804/c4 | World of Medicine Lemke GmbH | GCJ | Class II | |
| K014138 | Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement | Pulpdent Corporation | DYH | Class II | |
| K014133 | Pulpdent No-Mix Orthodontic Bracket Adhesive | Pulpdent Corporation | DYH | Class II | |
| K013572 | Mitek Biocryl Interference Screws | Mitek Products | HWC | Class II | |
| K013123 | Ems Pulmonary Function Testing Filter | Engineered Medical Systems, LLC | BZG | Class II | |
| K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems, LLC | CAH | Class II | |
| K012796 | Amluck Automatic Digital Wrist, Blood Pressure Monitor Ak-3000/Ak-4000 | Amluck, Inc. | DXN | Class II | |
| K012448 | Vectorvision Trauma | Brainlab, Inc. | HAW | Class II | |
| K012350 | Medpor Plus Surgical Implant Biomaterial | Porex Surgical, Inc. | FWP | Class II | |
| K020606 | Nva-63-8 Neurovascular Array Coil | Mri Devices Corp. | MOS | Class II | |
| K020599 | Mtp Clearvision Disposable Tubing Set | Mtp Medical Technical Promotion GmbH | EOB | Class II | |
| K020573 | Modification to Magnetom Rhapsody System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K020446 | Modification to Straight-in Bone Screw Fixation System | American Medical Systems, Inc. | HWC | Class II | |
| K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | CAW | Class II | |
| K020241 | Qaca Igg/igm Elisa Kit | Cheshire Diagnostics, Ltd. | MID | Class II | |
| K020200 | Playtex Deodorant Tampons, Model 34802 | Playtex Products, Inc. | HIL | Class II | |
| K020190 | Portadur P 4 | Wieland Dental + Technik GmbH & Co. KG | EJT | Class II | |
| K020183 | Pisces Plus (Dw286 C) | Ivoclar Vivadent, Inc. | EJH | Class II | |
| K020015 | Implant Guidance System Applicator Set | Nucletron BV | JAQ | Class II | |
| K014230 | Sterile Powder Free Latex Surgeon Gloves with Protein Labeling Claim (50 Microgram or Less) | Supermax Glove Manufacturing Sdn Bhd | KGO | Class I | |
| K013492 | Imubind Tpa Elisa, Model 860 | Sekisui Diagnostics, LLC | GGP | Class II | |
| K013314 | Opiates | Abbott Medical | DJG | Class II | |
| K013247 | Cannabinoids | Abbott Medical | LDJ | Class II | |
| K013143 | Benzodiazepines | Abbott Medical | JXM | Class II | |
| K013096 | Phencyclidine | Abbott Medical | LCM | Unclassified | |
| K013004 | Cocaine | Abbott Medical | DIO | Class II | |
| K012998 | Amphetamine/methamphetamine | Abbott Medical | LAF | Class II | |
| K012983 | Acist 4 French Angiographic Catheter | Acist Medical Systems, Inc. | DQO | Class II | |
| K012805 | Automarqer | Hamilton Thorne Research | POV | Class II | |
| K020725 | Microlife Digital Infrared Ear Thermometer, Model Ir1de1 | Microlife Corp. | FLL | Class II | |
| K020544 | Wing Safe Infusion Set 20 Ga, Shs2000 Series; Wing Safe Infusion Set 19 Ga, Shs1900 Series; Wing Safe Infusion Set 22 Ga | Vygon Mfg | FPA | Class II | |
| K020485 | All-in-One Two Chamber Container 3200 Ml, 2000 Ml & 1000 Ml | Baxter Healthcare Corporation | KPE | Class II |