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 |
|---|---|---|---|---|---|
| K021312 | Ebi Dfs Optirom Elbow Fixator | Ebi, LLC | KTT | Class II | |
| K021286 | Microselectron Hdr- Genie Afterloading System, Model 105.989 for 115Volt Devices and 105.988 for 230Volt Devices | Nucletron BV | JAQ | Class II | |
| K020914 | Actalyke Xl Activated Clotting Time Analyzer, Model 5770 | Helena Laboratories, Corp. | JBP | Class II | |
| K020684 | Finesun Ems Stimulator | Finesun Worldwide Intl. Co., Ltd. | IPF | Class II | |
| K020620 | Blackstone III Degree Anterior Cervical Plating System (Plate Washer) | Blackstone Medical, Inc. | KWQ | Class II | |
| K020587 | Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing Pv 4046 | Pulsion Medical Systems AG | KRB | Class II | |
| K020439 | Status Hcg Serum/urine | Princeton BioMeditech Corp. | JHI | Class II | |
| K020321 | Bd Phoenix Automated Microbiology System | Becton Dickinson & Co | LON | Class II | |
| K014193 | Lifesign Doa 4 (Thc/opi/coc/met) | Princeton BioMeditech Corp. | LDJ | Class II | |
| K014192 | Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status Ds Met | Princeton BioMeditech Corp. | MVO | Unclassified | |
| K013960 | Apatight Ha-Bone Graft Substitute | Cerabio, LLC | MQV | Class II | |
| K013390 | Quickclot | On Site Gas Systems Inc. | QSY | Unclassified | |
| K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and without Pre-Shaped Tips | Cordis Neurovascular, Inc. | KRA | Class II | |
| K021491 | Hispeed Dual | GE Healthcare | JAK | Class II | |
| K021465 | Midas Touch Latex Examination Gloves-Polymer Coated, Powder Free | Industrial Clothings, Ltd. | LYY | Class I | |
| K021460 | Oco Dental Implant | O Co., Inc. | NHA | Class II | |
| K021447 | Tele-Cliniq Data Transmission System Blood Pressure Measurement System | Aerotel Medical Systems (1998), Ltd. | DXN | Class II | |
| K021435 | Dinamap Pro Series Monitor, Models 110N,210n,310n,410n | GE Medical Systems Information Technologies, Inc. | MWI | Class II | |
| K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | DQX | Class II | |
| K021268 | Eclipse, Helios Option | Varian Medical Systems, Inc. | MUJ | Class II | |
| K021225 | Rossmax Automatic Blood Pressure Monitor, Model Cardiocare 1000I | Rossmax International Ltd. | DXN | Class II | |
| K021082 | On Site Gas Systems Portable Oxygen Generation System-1.0 and 5.0 | On Site Gas Systems Inc. | CAW | Class II | |
| K021013 | Smart Glove Sterile Nitrile Examination Gloves (Powdered Free) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K020909 | Hdm99 | Ibp Instruments GmbH | FIZ | Class II | |
| K020908 | Hdm97 | Ibp Instruments GmbH | FIZ | Class II | |
| K020774 | Imagine H.e. Press Design-Ceramic | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K020730 | Orion Nasal CPAP System | Bird Products Corp. | BZD | Class II | |
| K020600 | Blackstone III Anterior Cervical Plating System (Plate Washer) | Blackstone Medical, Inc. | KWQ | Class II | |
| K020584 | N2000 Base Station; N2001 Nurse Station | Neptec Design Group, Ltd. | DXN | Class II | |
| K020577 | Applied Ureteral Catheter | Applied Medical Resources Corp | EYB | Class II | |
| K020465 | Medcomp Ash Split-Cath II | Medcomp | MSD | Class II | |
| K014283 | Latex Surgeons Glove (Powder Free) | Brightway Gloves Pvt., Ltd. | KGO | Class I | |
| K013846 | Ultragard Impervious Reinforced Gown | Precept Medical Products, Inc. | FYA | Class II | |
| K013642 | Avea | Bird Products Corp. | CBK | Class II | |
| K021530 | Simplicity Easy P Soft Infusion Set for Infusion And/or Injection of Fluids into the Body Below the Surface of the Skin | Sterling Medivations, Inc. | FPA | Class II | |
| K021522 | Lorenz 1.5 X 4 Mm Lactosorb Tap Free Screw | Biomet Microfixation | DZL | Class II | |
| K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | ETB | Class II | |
| K021331 | Dexacare G4 | Osteometer Meditech A/S | KGI | Class II | |
| K021310 | 36Mm C-Taper Femoral Head Components (Lfit and Non-Lfit) | Howmedica Osteonics Corp | JDI | Class II | |
| K021272 | Sib Catheter, Model 61-7005 | Ackrad Laboratories | LKF | Class II | |
| K021262 | Magnetom Symphony Quadrature Tx/rx Head Coil | GE Healthcare Coils | MOS | Class II | |
| K020993 | Illuminator Automatic Tune Vox and Interface Cable (Atib) | Magna-Lab, Inc. | MOS | Class II | |
| K020846 | Ultima TENS Xl-A1 | Tenscare Ltd. | GZJ | Class II | |
| K020790 | Intercept Esophageal Internal Mr Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal Mr Coil | Surgi-Vision, Inc. | MOS | Class II | |
| K020563 | Medamicus Axia Rsn | Greatbatch Medical | DYB | Class II | |
| K013982 | Kinematch Patello-Femoral Resurfacing Impalant | Kinamed Inc | KRR | Class II | |
| K013897 | Solid State X-Ray Imaging Devices, Model Iris 20 and Iris 41 with Iris View | Bio-Scan, Inc. | MQB | Class II | |
| K013827 | Tst - Suppressor Model #1000 | Neurosim Limited | KLW | Class II | |
| K021343 | Isoseeds I-125 | Bebig Isotopen-Und Medizintechnik GmbH | KXK | Class II | |
| K021025 | Modification to Hedrocel Vertebral Body Replacement, Model Xx-Yyy-Zzzz | Implex Corp. | MQP | Class II |