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 |
|---|---|---|---|---|---|
| K081977 | Prosit Wound Treatment Device | Silverleaf Medical Products, Inc. | FRO | Unclassified | |
| K082674 | Spectra-Glass Lor (Loss of Resistance Syringe, 5Cc Metal L/s or L/l Tip, Spectra-Glass Lor (Loss of Resistance) Syringe | Spectra Medical Devices, LLC | FMF | Class II | |
| K082540 | Ge Entropy Sensor | GE Healthcare | GXY | Class II | |
| K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corp. | HSX | Class II | |
| K082011 | Medistim Xp, Type 281 and Meditens Xp, Type 458 | Bio-Medical Research, Ltd. | GZJ | Class II | |
| K080278 | Tabataba Cotester | Fim Medical | CCJ | Class II | |
| K080241 | Dds Stabilization System | Paradigm Spine GmbH | NQP | Class II | |
| K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console | Levitronix, LLC | DWA | Class II | |
| K083321 | Cardio-View | Curlview Igt, LLC | DXJ | Class II | |
| K083181 | Qv-9000 Universal System | Quantum Medical Imaging, LLC | KPR | Class II | |
| K083115 | Modification to Intel Health Guide, Model Phs6000 | Intel Corp. | DRG | Class II | |
| K083078 | Quanta Blood Pressure Meter, Model: Cardiac Elite 1000 or Qh200 | Quanta Computer Inc | DXN | Class II | |
| K083039 | Veritas Collagen Matrix (Dry) | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | Class II | |
| K082888 | Infinity Nellcor Oximax Smartpod, Model Ms23997 | Draeger Medical Systems, Inc. | DQA | Class II | |
| K082785 | Nihon Kohden Bedside Monitor, Bsm 9100A Series | Nihon Kohden America Inc | MHX | Class II | |
| K082740 | Gc Aadva Zr Disk | GC America Inc. | EIH | Class II | |
| K082730 | Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate Apical and Posterior Prolapse | American Medical Systems, Inc. | OTP | Class III | |
| K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | HGM | Class II | |
| K082600 | Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082) | Draeger, Inc. | CBK | Class II | |
| K082541 | Healthline Medicator / Redineb Aerosol Drug Delivery System | Medi Nuclear Corp., Inc. | CAF | Class II | |
| K081975 | Relion Ultima Advance Blood Glucose Monitoring System Models, Bgms 71030-01 Strips: 7103-01 (20 Count) | Abbott Medical | NBW | Class II | |
| K080650 | Omni-Dl System | Transvivo, Inc. | KDI | Class II | |
| K080446 | Rapidvit and Rapidwarm Cleave | Vitrolife Sweden AB | MQL | Class II | |
| K080398 | Si Joint Fusion System | SI-Bone, Inc. | OUR | Class II | |
| K083139 | Vipersphere Pta Balloon Catheter | Cardiovascular Systems Incorporated | DQY | Class II | |
| K082949 | Orthopediatrics Bone Screws | Orthopediatrics Corp | HWC | Class II | |
| K082861 | Amco Replacement Battery for Powerheart AED, Non-Rechargeable, Model 2L561; G3, Non-Rechargable, Model 7L561 | Amco International Manufacturing & Design, Inc. | MKJ | Class III | |
| K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve | Encore Medical, LP | LZO | Class II | |
| K082838 | Orlus Mini Screw | Ortholution Co., Ltd. | DZE | Class II | |
| K082655 | Envitec Medical Oxygen Senors, Models Oom101; 00M102/-1;Oom103/-1/-1M;oom104;oom105;00m106 | Envitec-Wismar GmbH | CCL | Class II | |
| K082654 | Enteral Only Extension Set | Respironics, Inc. | KNT | Class II | |
| K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes | Apatech Ltd. | MQV | Class II | |
| K082415 | Prodigy Npwt System Model Prodigy 800V | Premco Medical Systems, Inc. | OMP | Class II | |
| K082358 | Smith & Nephew, Inc. Patient Matched Technology | Smith & Nephew, Inc. | JWH | Class II | |
| K082253 | Bodystat 1500 Body Composition Monitoring Unit | Bodystat Ltd | MNW | Class II | |
| K082200 | Klockner Essential Dental Implants System, Model Essential Cone 1.5 | Soadco, S.L. | DZE | Class II | |
| K082153 | Major.repair | Major Prodotti Dentari S.p.A. | EBI | Class II | |
| K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | HAW | Class II | |
| K080649 | Pogo Screw | Fxdevices | HWC | Class II | |
| K080467 | Bionexa Single and Multi-Strip Cassette/dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, Mtd, Mor, Pcp, Tca, Thc, | Applied Dna Technologies, Inc. | LDJ | Class II | |
| K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | NEY | Class II | |
| K083228 | Philips Intellivue Mp5 Patient Monitor | Philips Medizin Systeme Boblingen GmbH | MHX | Class II | |
| K082963 | Wu's 4-Wheeled Neo Scooter, Wt-M3a | Wu's Tech Co., Ltd. | INI | Class II | |
| K082881 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3 | Microlife Intellectual Property GmbH | DXN | Class II | |
| K082807 | Synthes (USA) 3.5 and 4.5 Mm Locking Compression Plate System with Expanded Indications | Synthes (USA) Products LLC | HRS | Class II | |
| K082753 | Futurabond M/futurabond M Single Dose | Voco GmbH | KLE | Class II | |
| K082572 | Uss Iliosacral, Uss Polyaxial | Synthes GmbH | NKB | Class II | |
| K082002 | Progenix Plus | Medtronic Sofamor Danek | MQV | Class II | |
| K081943 | Model Es-130 | Ito Co., Ltd. | BWK | Unclassified | |
| K083255 | 16Ch Ai Breast Coils 1.5 T and 3 T | Rapid Biomedical GmbH | MOS | Class II |