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 |
|---|---|---|---|---|---|
| K983591 | Intratubal Transfer Sets | Cook Ob/Gyn | MQF | Class II | |
| K983590 | Gift Catheter Set/s | Cook Ob/Gyn | MQF | Class II | |
| K983568 | Ostar D'pro Latex Powdered Examination Gloves, Protein Claim of 100 Mcgm Or/less of Total Water Extractable Protein per | Contract Latex Dippers Sdn Bhd | LYY | Class I | |
| K983485 | Synthes 1.3 Mm Self-Drilling Screw | Synthes (USA) Products LLC | DZL | Class II | |
| K983413 | Model Ms-1 Handpiece | Parkell, Inc. | EKX | Class I | |
| K983342 | Mr Guided Procedures (Mrgp) Basic Package | Philips North America LLC | LHN | Class II | |
| K982901 | Latex Patient Examination Glove, Cat. No. 1000M Powdered | Vitalcare Group, Inc. | LYY | Class I | |
| K982535 | Insight Diagnostic Imaging Workstation | Neo Imagery Technologies, Inc. | LLZ | Class II | |
| K984400 | Liquichek Ana Control, Speckled Pattern, Model 202 | Bio-Rad | DHN | Class II | |
| K984399 | Liquichek Ana Control, Nucleolar Pattern, Model 204 | Bio-Rad | DHN | Class II | |
| K984398 | Liquichek Ana Control, Homogeneous Pattern, Model 201 | Bio-Rad | DHN | Class II | |
| K984397 | Liquichek Ana Control, Centromere Pattern, Model 203 | Bio-Rad | DHN | Class II | |
| K984396 | Liquichek Anti-Dsdna Control, Model 213 | Bio-Rad | LRM | Class II | |
| K984383 | Ultracare Neutralizing Tablets | Allergan | LPN | Class II | |
| K984302 | Osteonics Spinal System Cylindrical Bone Screws | Osteonics Corp. | MNH | Class II | |
| K984245 | Non-Invasive Dynamic Reference Frame (Drf) for Optical Tracking System, Model Ots | Radionics, Inc. | HAW | Class II | |
| K984177 | Modification to Skvekpatch | Marine Polymer Technologies, Inc. | KMF | Class I | |
| K984110 | Laserscope Coolspot | Laserscope | GEX | Class II | |
| K983973 | Opti-One Multi-Purpose Solution | Alcon Laboratories | LPN | Class II | |
| K983924 | Hep-2000 Colorzyme Ana-Ro Test System, Model 4200-Ro | IMMUNO CONCEPTS, NA, Ltd. | DHN | Class II | |
| K983906 | Depuy Orthotech Spiked Washer | Depuy Orthopaedics Inc. | HTN | Class II | |
| K983880 | Transferrin Spq III Antibody Reagent Set | Diasorin Inc. | DDG | Class II | |
| K983780 | Multi-Purpose Disinfecting Solution Id 90746 | Alcon Laboratories | LPN | Class II | |
| K983777 | Modification to Venture Iho 100 Complete Home Oxygen System | Invacare GmbH | CAW | Class II | |
| K983766 | Synthes Synmesh | Synthes (USA) Products LLC | EZX | Class II | |
| K983758 | Yasargil Titanium Aneurysm Clips | Aesculap Inc | HCH | Class II | |
| K983741 | Everlast Neurostimulation Electrodes 2X 2,Model # El2020 | Axelgaard Mfg. Co., Ltd. | GXY | Class II | |
| K983733 | Sulzer Orthopedics Apollo Revision/constrained Knee Tibial Baseplate Stem Plugs | Sulzer Orthopedics, Inc. | JWH | Class II | |
| K983663 | C.t.m. Mobility Scooter, Model # Hs-666 | Warepalmy Enterprise, LLC (USA) | INI | Class II | |
| K983662 | C.t.m. Mobility Scooter, Model # Hs-686 | Warepalmy Enterprise, LLC (USA) | INI | Class II | |
| K983623 | Modulap | Atc Technologies Inc. | GCJ | Class II | |
| K983557 | Stryker Wedge Suture Anchor | Stryker Corp. | MBI | Class II | |
| K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K983501 | Accusign Doa 10,Accusign Doa Panel,accusign Met/opi/coc/thc/pcp/bzo/bar/mtd/tca/amp,biosign Doa 10, Biosign Met/opi/coc/ | Princeton BioMeditech Corp. | LAG | Class II | |
| K983448 | Ml Universal Tubing | Med-logics Inc | MSR | Class II | |
| K983365 | Aesculap Minop System | Aesculap Inc | GWG | Class II | |
| K983363 | Dci Endoscope | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K983353 | Scs Spinal System | Orthotec, Inc. | KWP | Class II | |
| K983306 | Sensititre 18-24 Hour Susceptibility Plates with Grepafloxacin | Accumed Intl., Inc. | LTT | Class II | |
| K983297 | Medtronic Instent Esophacoil Esophageal Stent System with Slow Release | Medtronic Instent, Inc. | ESW | Class II | |
| K983031 | Vitros Immunodiagnostic Products Afp Assay | Ortho-Clinical Diagnostics, Inc. | LOJ | Class II | |
| K982712 | Rapid Transfer Blood Bag Model a-1650, Rapid Transfer Blood Bag Model S-250 | Genzyme Surgical Product (Genzyme Biosurgery) | CAC | Class II | |
| K982379 | Sundt Slim-Line Aneurysm Clip Applier | Johnson & Johnson Professionals, Inc. | HCI | Class II | |
| K980823 | Cordis Nitinol Stent and Delivery System | Cordis US Corp. | FGE | Class II | |
| K980184 | Cd Spinal System | Sofamor Danek USA,Inc. | MNI | Class II | |
| K980117 | Nuvo Barrier Film | Biomedical Development Co. | KMF | Class I | |
| K984347 | The Aptus (Automated) Application of the Anti-Cardiolipin Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (F | Zeus Scientific LLC | MID | Class II | |
| K984325 | Architect Ferritin Mastercheck, Model Number 6C11-05 | Bio-Rad | JJY | Class I | |
| K984315 | The Aptus (Automated) Application of the Pr-3 Elisa Test System. an Aneyme Linked Immunosorbent Assay (Elisa) for the De | Zeus Scientific LLC | MOB | Class II | |
| K984286 | Heartstream Electrode Adapter | Hewlett-Packard Co. | MKJ | Class III |