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 |
|---|---|---|---|---|---|
| K063231 | Microblade Shaver and Accessories | Baxano, Inc. | HAE | Class II | |
| K062130 | Meisinger Benex, Model Be001 | Hager & Meisinger GmbH | EMG | Class I | |
| K062102 | Odoncer | Teknimed SAS | LYC | Class II | |
| K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | OMP | Class II | |
| K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | OOD | Class II | |
| K070871 | Starion Universal Power Supply | Microline Surgical, Inc | HQO | Class II | |
| K070851 | Arthrocare Spinewands | ArthroCare Corporation | GEI | Class II | |
| K070817 | Leradotech Scooter, Model Sb | Lerado China Limited | INI | Class II | |
| K070802 | Leradotech, Model Sc | Lerado China Limited | INI | Class II | |
| K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons | Playtex Products, Inc. | HIL | Class II | |
| K070718 | Modification to: Bodyguard Infusion System | Caesarea Medical Electronics, Ltd. | FRN | Class II | |
| K070574 | Flexitron | Isodose Control B.V. | JAQ | Class II | |
| K070397 | Dgscope, Release 1.0 | Segami Corporation | LLZ | Class II | |
| K070207 | Multi-Analyte Chemistry Calibrator | Horiba Instruments Incorporated | JIX | Class II | |
| K070136 | Audicor 200 System, Models 200D and 200S | Inovise Medical, Inc. | DPS | Class II | |
| K070056 | Vapotherm Model# 2000I and 2000H | Vapotherm Inc. | BTT | Class II | |
| K063606 | Modification to Staxx Fx System | Spine Wave Inc | OBL | Class II | |
| K063125 | Filterflo Hepa; Thermoflo Hepa (Filter / Hme) | Arc Medical, Inc. | CAH | Class II | |
| K063071 | Discyphor Catheter System, Model D01a; Discyphor Introducer Needle, Model D01b | Medtronic, Inc. | BSP | Class II | |
| K062526 | Blue Powdered Latex Examination Gloves, Non-Sterile | Multisafe Sdn Bhd | LYY | Class I | |
| K062449 | Empowermr Injector System, Model 9730 | E-Z-EM, Inc | IZQ | Class II | |
| K062362 | Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters | Sarmed SRL | KLA | Class II | |
| K062325 | Rs-4I Muscle Stimulator Family | RS Medical | NYN | Class II | |
| K070854 | Gc Mi Paste Plus | GC America Inc. | EJR | Class I | |
| K070683 | Mirage Cedars Option | Segami Corporation | LLZ | Class II | |
| K070649 | Sms Glucose Control, Model 2120061 | Spectrum Medical Supply, Inc. | JJX | Class I | |
| K070454 | Omega 3 Supracondylar Plate | Howmedica Osteonics Corp | KTT | Class II | |
| K070367 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | NKB | Class II | |
| K070220 | Osteofix Bone Void Filler | Calcitec, Inc. | MQV | Class II | |
| K070167 | Endobutton Direct | Smith & Nephew, Inc. | MBI | Class II | |
| K062631 | Myomo E100 | Myomo, Inc. | OAL | Class II | |
| K062473 | Liaison Borrelia Igg/igm Assay, Model 310870; Serum Controls, Model 310871 | Diasorin Inc. | LSR | Class II | |
| K061896 | Mediaid Disposable Non-Adhesive Sensors, Model Cst050-2101N; Reusable Finger Clip Sp02 Sensors, Model Cst060-2101N | Mediaid, Inc. | DQA | Class II | |
| K061277 | Straumann Computer Aided Restoration Service (C.a.r.e.s.) Ceramic Coping | Straumann USA, LLC | NHA | Class II | |
| K053492 | Bioduct | Bioduct, LLC | MAI | Class II | |
| K070884 | Pod B-Scan | Starfish Product Engineering | IYO | Class II | |
| K070866 | Asc-12 Piezoelectric Scaler | Aseptico, Inc. | ELC | Class II | |
| K070847 | Trial Cable, 3009 | Abbott Medical | GZB | Class II | |
| K070782 | Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models Hc-Nb095f and Hc-Nb295f | Survivair Respirators, LLC | MSH | Class II | |
| K070778 | Neocoil 3.0T 6-Channel Carotid Array Coil | NeoCoil, LLC | MOS | Class II | |
| K070706 | Ep-Workmate | Abbott Medical | DQK | Class II | |
| K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-Vu Inspiratory Flow Indicator | Trudell Medical Intl. | NVP | Class II | |
| K070504 | Ammonia/alcohol Control Set | Horiba Instruments Incorporated | JJY | Class I | |
| K070066 | Quanta Lite RNA Pol III Elisa | Inova Diagnostics, Inc. | NYO | Class II | |
| K063701 | Teco Homocysteine Enzymatic Assay | Teco Diagnostics | LPS | Class II | |
| K063098 | Static Cranioplasty Orthosis | Boston Brace Intl., Inc. | OAN | Class II | |
| K062797 | Powdered Latex Surgical Glove | Beijing Reagent Latex Products Co., Ltd. | KGO | Class I | |
| K062194 | Hypervisor VI Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K070850 | Freestyle Lite Blood Glucose Monitoring System | Abbott Medical | NBW | Class II | |
| K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | IYN | Class II |