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 |
|---|---|---|---|---|---|
| K955645 | Cath-Guide | Hudson Respiratory Care, Inc. | BSY | Class I | |
| K955426 | Steritec Cross-Checks | Steritec Products Mfg. Co., Inc. | JOJ | Class II | |
| K955338 | Drytime for Potty Training | Health Sense Intl., Inc. | KPN | Class II | |
| K954556 | Surgical Cap | Thai Disposable Products Co., Ltd. | FYF | Class I | |
| K954415 | Patient Examination Gloves with Protein Labeling Claim | Hartalega Sdn Bhd | LYY | Class I | |
| K954164 | Hysteroscope | Conceptus, Inc. | HIH | Class II | |
| K954006 | Yellow Iris Urinalysis Workstation W/iriscope Body Fluid Analysis Capability | Intl. Remote Imaging Systems | GKL | Class II | |
| K953392 | Hc500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | BTT | Class II | |
| K952095 | Vitek Gram Positive Identification Card (Gpi) | Biomerieux Vitek, Inc. | LQL | Class I | |
| K960793 | Synermed Enzymatic CO2 Reagent Kit | Synermed, Inc. | KHS | Class II | |
| K960791 | Karl Storz Huzly High-Frequency Cutting Loops | Karl Storz Endoscopy-America, Inc. | EOQ | Class II | |
| K960569 | Disposable Patient Return Electrode | Erbe USA Inc | GEI | Class II | |
| K960266 | Siregraph Cf | Siemens Medical Solutions USA, Inc. | JAA | Class II | |
| K960261 | Pallikaris Brush | Alcon Laboratories | HOG | Class I | |
| K960220 | Sensititre 18 Hour Susceptibility Plates | Sensititre, Ltd. | JWY | Class II | |
| K960120 | Stat Profile Ultra F,g,h,i,j, and K Analyzers | Nova Biomedical Corporation | JFP | Class II | |
| K960099 | Penrose Drain Models 6001 - 6007 | Sil-Med Corp. | GCY | Class I | |
| K960085 | Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak Systems | Alko Diagnostic Corp. | JIX | Class II | |
| K955932 | Exaflex Impression Material (Modification) | GC America Inc. | ELW | Class II | |
| K955928 | Barbiturate Eia Essay (Modification) | Diagnostic Reagents, Inc. | DIS | Class II | |
| K955886 | Mega Pta Balloon Catheter | Cordis US Corp. | LIT | Class II | |
| K955873 | Acs Phenytoin Assay | Ciba Corning Diagnostics Corp. | LGR | Class II | |
| K955735 | Kc 4A Micro Coagulation Analyzer Set/system | Sigma Diagnostics, Inc. | JPA | Class II | |
| K955637 | Essence Guidewire | Cordis Neurovascular, Inc. | DQX | Class II | |
| K955532 | Diastat Vascular Access Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K955403 | Oes Laparo-Thoraco Videoscope Type V | OLYMPUS Corporation of the Americas | HET | Class II | |
| K955125 | Lmi Occlusion Catheter | Lucas Medical, Inc. | DXE | Class II | |
| K954977 | Urine Reagents Strips-8 Parameters (Modification) | Teco Diagnostics | JRE | Class I | |
| K954696 | Rogozinski Thoracolumbar Spinal Rod | Smith & Nephew Richards, Inc. | KWP | Class II | |
| K954625 | Prothrombin Time Test Card | Cardiovascular Diagnostics, Inc. | GJS | Class II | |
| K954597 | Right Angle Laser Fibers | Trimedyne, Inc. | GEX | Class II | |
| K953854 | Watercheck Reagent Strip for Chlorine & Peroxide | Integrated Biomedical Technology, Inc. | FKP | Class II | |
| K953750 | Catheter, Electrode Recording, or Probe, Electrode Recording | Boston Scientific Corporation | DRF | Class II | |
| K953598 | Series 9100 Plus Automated Differential Hematology Analyzers | Serono Diagnostics, Inc. | GKZ | Class II | |
| K952540 | Sonos Imaging System (2000/2500 & 1000/1500) | Hewlett-Packard Co. | IYO | Class II | |
| K952321 | Porcine Factor Viii;c Reagent | Helena Laboratories, Corp. | GGN | Class II | |
| K943014 | Balloon Electrosurgical Probes and Devices | Ximed Medical Systems | GEI | Class II | |
| K960828 | Pos-T-Vac B-10 Band Kit | Pos-T-Vac, LLC | LKY | Class II | |
| K960371 | Interpore Threaded Implant | Interpore Intl. | DZE | Class II | |
| K960222 | Percutaneous Endoscopic Discectomy | Richard Wolf Medical Instruments Corp. | HRX | Class II | |
| K955778 | Natural-Knee II Unicompartmentalknee System | Intermedics Orthopedics | HRY | Class II | |
| K955701 | Nightguard Diagnostic Appliance | Cycura Corp. | MQC | Unclassified | |
| K955619 | 5.0Mm Spline Endosseous Dental Implant Systems | Calcitek, Inc. | DZE | Class II | |
| K955417 | Vital Pak | Vital Signs, Inc. | DXG | Class II | |
| K955057 | Model 1100 Cold Therapy Device | Smith and Nephew Donjoy, Inc. | ILO | Class II | |
| K954988 | Crystallessence | Confi-Dental Products Co. | EBF | Class II | |
| K954867 | Ionosit Seal | Foremost Dental Mfg., Inc. | EBC | Class II | |
| K954856 | Cannulated Femoral Nail | Synthes (USA) Products LLC | JDN | Class II | |
| K954429 | Kangaroo Entristar Skin-Level Gastrostomy Kit | Sherwood Medical Co. | KNT | Class II | |
| K954385 | Synthes Mandibular Modular Fixation System | Synthes (USA) Products LLC | JEY | Class II |