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 |
|---|---|---|---|---|---|
| K042534 | Marina Medical Finger Protectors | Marina Medical Instruments Inc. | KGO | Class I | |
| K041823 | Pioneer U121 Series CPAP | Merits Health Products, Inc. | BZD | Class II | |
| K050926 | Texan Longhorn Foreign Body Retrieval Device, Model Tx30120060 | Idev Technologies, Inc. | MMX | Class II | |
| K050786 | Barrier Surgical Gowns | Molnlycke Health Care | FYA | Class II | |
| K050541 | Omniguide Beampath CO2 Mark I Laser Beam Delivery | Omniguide Communications, Inc. | HQF | Class II | |
| K050312 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | LZG | Class II | |
| K050116 | Uniqsafe Rotatable, Retractable Safety Syringes | Uniqsafe Biomeditech Co., Ltd. | MEG | Class II | |
| K042421 | Uritek 151 Urine Analyzer, Model Tc-151 | Teco Diagnostics | KQO | Class I | |
| DEN050004 | Tag-It Cystic Fibrosis Kit | Tm Bioscience Corporation | NUA | Class II | |
| K051052 | Seednet Family (Seednet/seedgold System, Cryothera System, Cryo-Hit System) | Galil Medical Ltd. | GEH | Class II | |
| K050962 | Merit Prelude Sheath Introducer | Merit Medical Systems, Inc. | DRE | Class II | |
| K050835 | Datex-Ohmeda S/5tm Entropy Module, E-Entropy and Accessories | GE Healthcare | OLW | Class II | |
| K050829 | Nurse's Assistant 1.7 o.r. Control System | Conmed Integrated Systems (Cmis) | GCJ | Class II | |
| K050814 | Atrium Icast Covered Stent | Atrium Medical Corporation | JCT | Class II | |
| K050593 | Acon Bar II One Step Barbiturates Test Strip & Device | Acon Laboratories, Inc. | DIS | Class II | |
| K050470 | Concentric Embolic Pearls | Concentric Medical, Inc. | KRD | Class II | |
| K050119 | Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit | Siemens Healthcare Diagnostics Inc. | JKM | Class II | |
| K050012 | Ventana Image Analysis System | Becton Dickinson & Co | NQN | Class II | |
| K043586 | Laser Sys*stim 540, Model Me 540 | Mettler Electronics Corp | ILY | Class II | |
| K043044 | Anti-i.v. Enteral Feeding System | Viasys Medsystems | KNT | Class II | |
| K043036 | Non-Stick Electrode | Modern Medical Equipment Mfg., Ltd. | GEI | Class II | |
| K051085 | Doppler-Box | Compumedics Germany Gmgh | IYN | Class II | |
| K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | OXO | Class II | |
| K050941 | Brix Wheelchair | Meyra, Inc. | IOR | Class I | |
| K050934 | Modus Titanium Osteosynthesis System | Medartis AG | JEY | Class II | |
| K050890 | Ecc.o System | Dideco S.p.A. | KFM | Class II | |
| K050874 | Astra Tech Ab Lofric Primo Single Use Urinary Catheter | Astra Tech, Inc. | GBM | Class II | |
| K050812 | 90Xl Instrumentation System | Mesa Laboratories Inc | FIZ | Class II | |
| K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.r.l. | DQX | Class II | |
| K050736 | Imorgon Ultrasound Pacs Solutions | Sea Ridge Software, Inc. | LLZ | Class II | |
| K050356 | Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | FZP | Class II | |
| K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe | Technomed Europe | GXZ | Class II | |
| K050080 | Cynosurea Eclilite and Eclilite U | Cynosure, LLC | FTC | Class II | |
| K050022 | Medx Home | Medx Electronics, Inc. | ILY | Class II | |
| K050014 | Hemonir Tm | Nir Diagnostics, Inc. | GLY | Class II | |
| K043509 | Gunther Tulip Vena Cava Filter Set | Cook Inc. | DTK | Class II | |
| K043409 | Accuchanger | Direx Systems Corp. | IYE | Class II | |
| K041540 | Combosafe (Europe) and Promax (US) Surgical Gowns | Standard Textile Co., Inc. | FYA | Class II | |
| K041360 | Aldahol III High-Level Disinfectant | Healthpoint, Ltd. | MED | Class II | |
| K050938 | Knee Fusion Nail | Smith & Nephew, Inc. | JDS | Class II | |
| K050853 | Pmp4 Spiropro | Card Guard Scientific Survival, Ltd. | BZH | Class II | |
| K050849 | Ha Coated Lag Screw | Smith & Nephew, Inc. | KTT | Class II | |
| K050838 | The Lf-P Ceramic System | Jensen Industries, Inc. | EIH | Class II | |
| K050813 | Abc 2 Screw | Aesculap Inc | KWQ | Class II | |
| K050686 | Cardiovit at-10Plus | Schiller, AG | DPS | Class II | |
| K050612 | Lightspeed Cordless Endodontic Handpiece | Lightspeed Technology, Inc. | EKX | Class I | |
| K050589 | Ret-He Parameter on the Sysmex Model Xe-2100 Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K050573 | Neurolac Nerve Guide | Polyganics B.V. | JXI | Class II | |
| K050561 | Windsurfer | Medcon, Ltd. | DQK | Class II | |
| K050484 | Basis Spinal System | Medtronic Sofamor Danek | KWP | Class II |