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 |
|---|---|---|---|---|---|
| K072807 | I Light | Dent'N Co | EBZ | Class II | |
| K072619 | Nexgen Complete Knee Solution Lps-Flex and Knee Gender Solutions Female (Gsf) Porous Femoral Components | Zimmer GmbH | MBH | Class II | |
| K072618 | Twin-Pass Otw Catheter, Model 5201 | Vascular Solutions LLC | DQY | Class II | |
| K072480 | Generation 8 Se Adhesive | Pentron Clinical Technologies | KLE | Class II | |
| K072398 | Rt300-S and Rt300-Sp Fes Cycle Ergometer | Restorative Therapies Inc. | GZI | Class II | |
| K072372 | Phlebopress Model 601A Compression Therapy Device | Mego Afek | JOW | Class II | |
| K071958 | Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits | Abbott Medical | BTT | Class II | |
| K071927 | Modification to Vertebroplastic Radiopaque Bone Cement | Depuy Spine, A Johnson & Johnson Company | NDN | Class II | |
| K071655 | Reveal Dx Insertable Cardiac Monitor, Reveal Patient Assistant, Model(s) 9528,9538 | Medtronic, Inc. | DSI | Class II | |
| K071641 | Reveal Xt; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) | Medtronic, Inc. | DSI | Class II | |
| K071521 | Terumo Hx2 Temperature Management System | Terumo Cardiovascular Systems Corporation | DWC | Class II | |
| K071406 | Autosuture Endo Clip III 5 Mm Clip Applier | United States Surgical, A Division of Tyco Healthc | FZP | Class II | |
| K071228 | Fidelity 200 Cardiac Event Recorder | Signalife, Inc. | DXH | Class II | |
| K073099 | Fmri Hardware System | NordicNeuroLab AS | LNH | Class II | |
| K073035 | Prelude and Prelude Pro Sheath Introducers | Merit Medical Systems, Inc. | DRE | Class II | |
| K072986 | Integradweb Pacs System | GE Healthcare | LLZ | Class II | |
| K072858 | Tc-Plus Primary Knee System | Smith & Nephew, Inc. | JWH | Class II | |
| K072661 | Immunocap Thyrlobulin Immunocap | Phadia AB | JNL | Class II | |
| K072556 | Hemostasis Valve | Merit Medical Systems, Inc. | DTL | Class II | |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath | Cook Incorporated | FFS | Class II | |
| K072286 | Bis EEG Vista Monitor System and Bisx | Aspect Medical Systems, Inc. | OLW | Class II | |
| K072268 | Hc Wbc Hematology Control, Model: Wbc00s | R & D Systems, Inc. | JPK | Class II | |
| K072133 | Avaflex Vertebral Augmentation Needle | Medtronic, Inc. | NDN | Class II | |
| K071967 | Sysmex Xe-5000 | Sysmex America, Inc. | GKZ | Class II | |
| K071729 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | NQI | Class II | |
| K071579 | Pef Tube | N.M. Beale Co., Inc. | KNT | Class II | |
| K070691 | Bbl Chromagar 0157 | Becton Dickinson & Co | JSI | Class I | |
| K070228 | Implantium Prosthetics | Dentium Co., Ltd. | NHA | Class II | |
| K073180 | Smartsponge Plus System | Clearcount Medical Solutions, Inc. | LWH | Class I | |
| K072818 | Peri-Loc Periartricular Lck Pit Sys-Prox Fem Plates/screws.calbe Access | Smith & Nephew, Inc. | HRS | Class II | |
| K072778 | Brio Acupuncture Needles | Helio Medical Supplies, Inc. | MQX | Class II | |
| K072740 | Mondeal Extremity Bone Fixation System | Mondeal Medical Systems GmbH | HRS | Class II | |
| K072639 | Yuyuan Latex Examination Glove, Powdered | Shandong Yuyuan Latex Gloves Company, Ltd. | LYY | Class I | |
| K072502 | Modification to: Muse Cardiology Information System | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K072391 | Pfm Picc | PFM Medical GmbH | LJS | Class II | |
| K072309 | Microlux/blu | Addent, Inc. | EAZ | Class I | |
| K072202 | Carto 3 Navigation System (Model:fg-5400-00), Carto 3 External Reference Patches (Model:d-1283-01) | Biosense Webster Inc | DQK | Class II | |
| K072101 | Rigi-Fix Hip Stem System | Implants Intl. Ltd. | LPH | Class II | |
| K072030 | Implant Center | Satelec-Acteon Group | DZI | Class II | |
| K072022 | Valeo Pedicle Screw Spinal System | Amedica Corp. | NKB | Class II | |
| K071535 | Biolox Delta Ceramic Femoral Head | Zimmer GmbH | LZO | Class II | |
| K071371 | Copa Amd Antimicrobial Wound Dressing | Tyco Healthcare Group LP | FRO | Unclassified | |
| K063050 | Cap Plus | Etex Corp. | MQV | Class II | |
| K073165 | Drad-3000E, Radrex-I | Toshiba America Medical Systems, In.C | MQB | Class II | |
| K073134 | A-Series Integral Controller, Model Int/dl40i | Invacare GmbH | ITI | Class II | |
| K073133 | Interstitial Needles | Varian Medical Systems, Inc. | JAQ | Class II | |
| K073124 | Collimare Collimator Family | Collimare, LLC | IZW | Class II | |
| K073104 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | DRX | Class II | |
| K073032 | Primaconnex Sd Esthetic Contour Zi Abutments | Lifecore Biomedical LLC | NHA | Class II | |
| K072952 | Ge Echopac | General Electric Co. | LLZ | Class II |