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 |
|---|---|---|---|---|---|
| K081182 | Microscan Dried Gram-Positive Mic/combo Panels New Antimicrobial Test - Inducible Clindamycin | Siemens Corp. | JWY | Class II | |
| K081159 | Harvard Medical Devices Blood Pressure Monitor, Model Hmbpm-004/Kinetik Branded Bpm1 Series | Harvard Medical Devices, Ltd. | DXN | Class II | |
| K081021 | Kinetix Guidewire, Plus Guidewire | Boston Scientific Corporation | DQX | Class II | |
| K080990 | Depuy Global C.ap. Cta Resurfacing Shoulder | Depuy Orthopaedics Inc. | HSD | Class II | |
| K080737 | Miraflex High Flow Microcatheter | Cook Inc. | KRA | Class II | |
| K080432 | Mapersol | Preservation Solutions Inc | KDN | Class II | |
| K080273 | Ab-Trol and Private Label Glucose Control Solution | Fujirebio Diagnostics Texas, Inc. | JJX | Class I | |
| K080167 | Acs 180 and Advia Centaur Ft4 Immunoassays | Siemens Healthcare Diagnostics Inc. | CEC | Class II | |
| K073682 | Embletta Gold | Embla Systems | MNR | Class II | |
| K073664 | Frontline Medical Safetynet Guidewire Introducer | Injectimed, Inc. | MDM | Class I | |
| K081973 | Metha Short Stem Hip System; Modular Hip System; Excia Hip System | Aesculap Inc | LZO | Class II | |
| K081941 | Navigator Applications Suite | GE Healthcare Finland Oy | BSZ | Class II | |
| K081756 | Ocular Response Analyzer | Reichert, Inc. | HKX | Class II | |
| K081729 | Modification to Gfx Nerve Ablation System | Bioform Medical, Inc. | GXD | Class II | |
| K081636 | Peek-Optima Alif Spacer | Highridge Medical, LLC | MAX | Class II | |
| K081191 | Tcm Endo 20 | Nouvag AG | EKX | Class I | |
| K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope | Spine View, Inc. | HRX | Class II | |
| K080983 | Provent Nasal Cannula | Ventus Medical, Inc. | MNR | Class II | |
| K080930 | Modification to Automated Breast Ultrasound System, Model Abus | U-System, Inc. | IYO | Class II | |
| K080899 | Arctic Blast Intravenous Fluid Chiller | Medivance Inc. | NCX | Class II | |
| K080833 | Love Guard Male Latex Condom | Tianjin Human-Care Latex Corporation | HIS | Class II | |
| K080799 | Atlas-Based Autosegmentation | Elekta Limited | LHN | Class II | |
| K080606 | Alatech Powdered Latex Patient Examination Glove | Alatech Healthcare, LLC | LYY | Class I | |
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series | Zimmer GmbH | JDL | Class III | |
| K073396 | Antimicrobial Ultrasite Value, Ultrasite Ag | B.Braun Medical, Inc. | FPA | Class II | |
| K073047 | Aproxi 1100 and 4000 Series Dental Inlays | Aproxi ApS | EBF | Class II | |
| K071687 | Famili of Iridex Iq Laser Systems | Iridex Corporation | GEX | Class II | |
| K071649 | Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B | Wallac Oy | JIA | Class I | |
| K082157 | Kettosil and Silginat | Kettenbach GmbH & Co KG | ELW | Class II | |
| K082100 | Alltech Echostar 1.5 T Mr System | Alltech Medical Systems America, Inc. | LNH | Class II | |
| K082054 | Gyrus Acmi Plasmakinetic (Pk) Superpulse System, Model 744000 and Dual Footswitch Connector Cable, Model 710003 | Gyrus ACMI, Inc. | GEI | Class II | |
| K081921 | Ge Vivid E9 Ultrasound | General Electric Co. | IYN | Class II | |
| K081752 | Edge Pacs | Ashva Technologies, Pvt., Ltd. | LLZ | Class II | |
| K081721 | Tricos a Resorbable Substitute | Baxter Healthcare Corporation | LYC | Class II | |
| K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim S.A | HAW | Class II | |
| K080966 | Hyper-Box Topical Wound Oxygen System | Aoti, Ltd. | KPJ | Class II | |
| K080935 | Sonix Mdp Ultrasound Scanner | Ultrasonix Medical Corporation | IYN | Class II | |
| K080847 | Rfvision, Model 9.9D | Almana Medical Imaging | OWB | Class II | |
| K080484 | Inomax Ds (Delivery System), Model 10003 | Mallinckrodt Manufacturing LLC | MRN | Class II | |
| K072629 | Digimatch Robodoc Surgical System | Integrated Surgical Systems, Inc. | OJP | Class II | |
| K072486 | Modification to Hemcon Bandage and Hemcon Bandage OTC | Hem Con Medical Technologies, Inc. | QSY | Unclassified | |
| K072293 | Fossa Ureteral Open Stents | Fossa Medical, Inc. | FAD | Class II | |
| K081992 | Dimension Vista Csae Flex Regent Cartridge, Model K4108 | Siemens Healthcare Diagnostics Inc. | MKW | Class II | |
| K081968 | Modification to Lucent | Spinal Elements, Inc | MAX | Class II | |
| K081957 | U-Right Td-4247 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K081804 | Pioneer Plus Catheter | Medtronic, Inc. | PDU | Class II | |
| K081149 | Biopro Go-Ez Screw | Biopro, Inc. | HWC | Class II | |
| K080603 | Hybrid Nerve Location Needle Coated and Uncoated | Te ME NA SAS | BSP | Class II | |
| K080303 | Ez Regular | Meinntech Co., Ltd. | FPA | Class II | |
| K080298 | Dermabiosafe | Complete Product Resources | GXY | Class II |