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 |
|---|---|---|---|---|---|
| K072322 | Ultra Fast-Fix and Ultra Fast-Fix Ab Meniscal Repair Systems | Smith & Nephew, Inc. | GAT | Class II | |
| K072317 | Modification To:tsrh Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K072315 | Midas Rex Curved Bur | Medtronic Powered Surgical Solutions | HBE | Class II | |
| K072184 | Vitoss Bioactive Foam Bone Graft Substitute | DSM Biomedical, Inc. | MQV | Class II | |
| K071922 | Interplate Interbody Fusion Device, Models C, Cgc, L and Lgc | RSB Spine LLC. | OVD | Class II | |
| K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | FTL | Class II | |
| K071832 | Modifcation to: Spyglass Irrigation System | Medical Scientific, Inc. | LJH | Class II | |
| K071553 | Endoscopic Plication System; Eps; Plicator | Ndo Surgical, Inc. | ODE | Class II | |
| K071546 | Eos | Biospace Med | KPR | Class II | |
| K070670 | Eyetracker/ideas | S.A. Instrumentation Difra | GWN | Class II | |
| K070387 | Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K072316 | Precious Plus Guide Catheter | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K071971 | Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model(s) Dzxxxa, Dzxxxa-Cal | Diazyme Laboratories, Inc. | LPS | Class II | |
| K071877 | Lanx Spinal Fixation System | Lanx, LLC | MNI | Class II | |
| K071798 | Mondeal Distal Radius System | Mondeal Medical Systems GmbH | HRS | Class II | |
| K071797 | Mondeal Hand Contour System | Mondeal Medical Systems GmbH | HRS | Class II | |
| K071704 | Sleeve and Button Soft Tissue Devices | Biomet Sports Medicine | MBI | Class II | |
| K071428 | Inqu | Isto Technologies, Inc. | MQV | Class II | |
| K071157 | Stryker Peek and Titanium Soft Eyelet Anchors | Stryker Corp. | HWC | Class II | |
| K070927 | Hemosil D-Dimer Hs | Instrumentation Laboratory Co. | DAP | Class II | |
| K070897 | Bonemedik, and Bonemedik-S | Meta Biomed Co., Ltd. | MQV | Class II | |
| K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test | Luminex Corporation | ODW | Class II | |
| K072445 | Integrated Brachytherapy Unit - Digital | Nucletron BV | KPQ | Class II | |
| K072439 | Ge Lunar Dpx & Prodigy Series Dexa Bone Densitometers with Mobile Kit | GE Medical Systems Ultrasound and Primary Care Dia | KGI | Class II | |
| K072320 | Greiner Vacuette Quickshield Complete | Greiner Bio-One North America, Inc. | FMI | Class II | |
| K072282 | Capless Li Pedicle Screw System | Xtant Medical Holdings, Inc. | MNH | Class II | |
| K072246 | Validate Sp1 Calibration Verification/linearity Test Set, Model 601 | Maine Standards Co. | JJY | Class I | |
| K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound di | IYN | Class II | |
| K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories | Endogastric Solutions, Inc. | ODE | Class II | |
| K071567 | Autosafe-Reflex Safety Needle, Autosafe Advantage Safety Needle | Autosafe-Refelx, Inc. | FMI | Class II | |
| K071499 | Columbus Total Knee System Mios Cr/ps Tibial Tray | Aesculap Inc | JWH | Class II | |
| K071449 | Brm3 Brain Monitor | Brainz Instruments, Ltd. | OMA | Class II | |
| K071239 | Total Protein Urine/csf Gen.3 | Roche Diagnostics GmbH | JGQ | Class II | |
| K071170 | Powder Free Nitrile Examination Gloves, Magenta and White Color Coated with Allogel | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K071067 | Bactrack Lcd Alcohol Detector | KHN Solutions LLC | DJZ | Class I | |
| K070812 | Disposable Laparoscopic Instrument | Modern Medical Equipment Mfg., Ltd. | GEI | Class II | |
| K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | KWP | Class II | |
| K070685 | Kendall Antimicrobial Drain Dressing for OTC Use, Model 6662 | Tyco Healthcare | FRO | Unclassified | |
| K063481 | Modification to Rx Herculink Elite Biliary Stent System | Abbott Vascular | FGE | Class II | |
| K063259 | Olympus Capsule Endoscope System | Olympus Medical Systems Corp. | NEZ | Class II | |
| K063048 | Trans-Catheter Extractor | Tran Pa-C, Inc. | ODY | Class II | |
| K062736 | Siascope V | Astron Clinica Limited | PSN | Class II | |
| K072539 | Cure Catheter | Cure Medical, LLC | EZD | Class II | |
| K072405 | Usgi Transport Endoscopic Access Device | Usgi Medical | FED | Class II | |
| K072387 | Karl Storz Video Rhino-Laryngscope System, Model 11101 Series | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K072278 | Brk Transseptal Needle | Abbott Medical | DRC | Class II | |
| K072150 | Dimer Acid Derived Nano-Hybrid Composite Restorative Material | Novocol, Inc. | EBF | Class II | |
| K071891 | Statis Dental Handpieces | Scican Ltd. | EFB | Class I | |
| K071082 | Stryker Modular Hip System | Howmedica Osteonics Corp | LZO | Class II | |
| K070640 | Architect Stat Troponin-1; Myoglobin | Fisher Diagnostics | MMI | Class II |