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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kit | Revvity Health Sciences, Inc. | JIA | Class I | |
| K190268 | Hydrofera Blue READY - Border | Hydrofera, LLC. | FRO | Unclassified | |
| K190003 | Vivid Aligners | Orthodent Laboratory, Inc. | NXC | Class II | |
| K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | OAT | Class II | |
| K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | EZL | Class II | |
| K192992 | Suglue 3 | 3M Deutschland GmbH | EMA | Class II | |
| K192858 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | PZH | Class II | |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | KWY | Class II | |
| K192140 | 7D Surgical System | 7D Surgical, Inc. | OLO | Class II | |
| K192109 | Koala | IB Lab GmbH | LLZ | Class II | |
| K192080 | iASSIST Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K191292 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Anhui Powerguard Technology Co., Ltd. | LYZ | Class I | |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | PLF | Class II | |
| K190868 | Cleerly Labs | Cleerly, Inc | LLZ | Class II | |
| K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC | KCT | Class II | |
| K190225 | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | PRJ | Class II | |
| K190144 | MucoPEG | Sunbio,Inc. | LFD | Unclassified | |
| K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | Zimmer GmbH | LPH | Class II | |
| K192168 | Idys ALIF ZP 3DTi | Clariance-SAS | OVD | Class II | |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | OCL | Class II | |
| K191634 | Scan Abutments and Comfort Caps | Dentium Co., Ltd. | NHA | Class II | |
| K191304 | EthanZir Zirconia | Besorah Dental Solutions NZ Limited | EIH | Class II | |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics Inc | PCH | Class II | |
| K190608 | Mei Ceramic Bracket | Orthosun Co., Ltd. | NJM | Class II | |
| K190330 | DRX-Evolution/Plus with Dual Energy | Eastman Kodak Company | KPR | Class II | |
| K190143 | LARS AC Band Device | Corin USA | HTN | Class II | |
| K190013 | WellDoc BlueStar | Welldoc | MRZ | Class II | |
| K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | MQV | Class II | |
| K192824 | Parcus Knotless AP Suture Anchors | Parcus Medical, L.L.C. | MAI | Class II | |
| K183465 | Allcem, Allcem Core | Dentscare Ltda | EMA | Class II | |
| K192440 | FDR SE Lite | FUJIFILM Corporation | MQB | Class II | |
| K192278 | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) | Uvision360, Inc. | HIH | Class II | |
| K192117 | Small VBR™ | Ulrich GmbH & Co. KG | MQP | Class II | |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia, Inc. | CFF | Class II | |
| K192087 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. Ltd. | NUH | Class II | |
| K191693 | Bc-5 | Reveallux, Corp | GEX | Class II | |
| K191650 | LEGION System | Alcon Laboratories | HQC | Class II | |
| K191631 | ZMAXX Dental Zirconia Blanks | Zmaxx Bioceramics, LLC | EIH | Class II | |
| K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.p.A. | LPH | Class II | |
| K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc | HAW | Class II | |
| K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | EBI | Class II | |
| K191312 | Perfect PFE | Tenscare Ltd. | KPI | Class II | |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | KWY | Class II | |
| K190898 | Sight OLO | Sight Diagnostics, Ltd. | GKZ | Class II | |
| K190855 | BD Acute Central Line | Bard Access Systems, Inc. (Bard Has Joined BD) | FOZ | Class II | |
| K190544 | XIHPOS™ ZFUZE™ Interbody Fusion System | Difusion Technologies | MAX | Class II | |
| K190344 | DePuy Corail AMT Hip Prosthesis | Depuy (Ireland) | LZO | Class II | |
| K190334 | MIMOSA Imager | Mimosa Diagnostics Inc. | MUD | Class II | |
| K190190 | WV1 Endoscope | 270SURGICAL | HET | Class II | |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | NBW | Class II |