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 |
|---|---|---|---|---|---|
| K954236 | Faceplate (Hearing Aid Kit) | Truetone Hearing Systems, Inc. | ESD | Class I | |
| K954146 | Utk-Dte Autilary Shield | Mallinckrodt Medical | KPY | Class I | |
| K953333 | Menstrual Tampon | Paragon Trade Brands, Inc. | HEB | Class II | |
| K952908 | EMG Disc Recording Electrode with Pin | Chalgren Enterprises, Inc. | GXY | Class II | |
| K952690 | EMG Disc Recording Electrode with Pin | Chalgren Enterprises, Inc. | GXY | Class II | |
| K952688 | Innova Rectal or Small Vaginal EMG Sensing Electrode | Empi | HIR | Class II | |
| K950245 | Unique Needle | Unique Management Ent., Inc. | FMF | Class II | |
| K950149 | Chemmate(tm) Lambda | Biotek Solutions, Inc. | DEH | Class II | |
| K944786 | Ria Latex Condom & Ria Color Condoms (Red, Green, Blue, Orange, Purple and Black) | Line One Laboratories & Trading Co. | HIS | Class II | |
| K941558 | Mayfield Child Disposable Skull Pin | Ohio Medical Instrument Co., Inc. | HBL | Class II | |
| K941258 | Latex Condom | Suretex, Ltd. | HIS | Class II | |
| K934150 | Biocide Cleaner/disinfectant | Juan Sierra | LRJ | Class I | |
| K934014 | Vacusol Plus Dental Vacuum Line Cleaner/disinfectant | Biotrol, USA, Inc. | LRJ | Class I | |
| K930021 | J Tongs | Jerome Medical | HAX | Class II | |
| K926094 | Protectrode System | The Electrode Store | GXZ | Class II | |
| K954733 | Access Cortisol Assay (Modification) | Bio-Rad Laboratories Inc. | CGR | Class II | |
| K954211 | Crispics | Merlin Engineering Works, Inc. | LLZ | Class II | |
| K954165 | Ptw-Mp3 & Ptw-Mp3s Automatic Water Phantom | Ptw-New York Corp. | IYE | Class II | |
| K953833 | Life Sound Sensor Amplifier-Lisa | Flowscan, Inc. | DQD | Class II | |
| K955272 | Take-Apart Arthro-Scissors, Gasping, Biopsy Punch Forceps for Arthroscopy | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K955077 | Anthos 2010 Reader | Anthos Labtec, Inc. | JJQ | Class I | |
| K955037 | Rigid Neuroview Endoscope | Neuro Navigational Corp. | HRX | Class II | |
| K954981 | Karl Storz Hempfling Dilation Set | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K954482 | Sendx 100 Ph, Blood Gas & Electrolyte Analysis System | Cirrus Medical,Inc. | CHL | Class II | |
| K954466 | Proform Porous Beaded Femoral Stem | Globus Medical, Inc. | LPH | Class II | |
| K954219 | Reality Long Stem Hip System | Kinamed Inc | JDI | Class II | |
| K954185 | Re-Bag Multi-Use Pouch, Large & Small | Miltex, Inc. | KCT | Class II | |
| K954160 | Msv-2000 Video Imaging System | Applitec, Ltd. | GCJ | Class II | |
| K953998 | Discetome Tissue Aspirator | T. Korossurgical Instruments Corp. | HRX | Class II | |
| K953637 | Cms Accuprobe 550/530 | Cryomedical Sciences, Inc. | GEH | Class II | |
| K952680 | Varapulse-2 | Staodyne, Inc. | IPF | Class II | |
| K945876 | Weco Endoscopic System with Fiber Optic Light | Wells Johnson Co. | EQH | Class I | |
| K955242 | Titanium Bird Beak Plier | Sybron Dental Specialties, Inc. | JEX | Class I | |
| K955027 | Degubond X-Lite | Degussa AG | EJT | Class II | |
| K955017 | Pulpdent Resilute | Pulpdent Corporation | EMA | Class II | |
| K954781 | Kowa Genesis Hand-Held Fundus Camera | Kowa Pharmaceuticals America, Inc. | HKI | Class II | |
| K954780 | Kowa Professional Fundus Camera Models Fx-500, Fx-500S, Fx-500C | Kowa Pharmaceuticals America, Inc. | HKI | Class II | |
| K954611 | Drager Pt4000 Phototherapy System | Drager, Inc. | LBI | Class II | |
| K954423 | Angioptic Angiographic Catheter | Boston Scientific Corporation | DQO | Class II | |
| K954313 | Focus Pc Balloon Dilatation Catheter | Cardio-Dynamics, Inc. | LIT | Class II | |
| K954297 | Celsite Venous Access System Otw | B.Braun Medical, Inc. | LJT | Class II | |
| K954242 | Circuit Tree Phacoemulsifier | Circuit Tree | HQC | Class II | |
| K954241 | Surgin Genisis Phacoemulsifier | Surgeon Surgical Instrumentation, Inc. | HQC | Class II | |
| K954240 | Evolution Phacomulsifier | U.S. Iol, Inc. | HQC | Class II | |
| K954192 | Impregum Penta | Espe GmbH & Co. KG. | ELW | Class II | |
| K953867 | Root Canal Length Measuring Device | J. Morita USA, Inc. | LQY | Unclassified | |
| K953626 | Syringe Magnifier | Innovative Premiums, Inc. | FMF | Class II | |
| K952620 | Optical Blanks: Benz55g Clear and Visibility Tinted | Benz Research and Development LLC | LPL | Class II | |
| K951231 | Orthopedic Packs | Sterile Concepts, Inc. | GAN | Class II | |
| K955295 | Splash & Go II | Kid'S Wheel-Chairs | IOR | Class I |