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 |
|---|---|---|---|---|---|
| K031158 | Swift 2.0, Model 132.001 | Nucletron BV | JAQ | Class II | |
| K030316 | Audicor Cor Sensor (and Accessory Adaptor) | Inovise Medical, Inc. | DRX | Class II | |
| K023735 | Lapman Laparoscope Manipulator System and Accessories, Model 900-001 | Medsys, S.A. | GCJ | Class II | |
| K032329 | Sa 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | IYN | Class II | |
| K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K032152 | Benco Admix | Southern Dental Industries, Inc. | EJJ | Class II | |
| K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | GEI | Class II | |
| K031943 | Bd Phoenix Automated Microbiology System - Cephalothin (Gn) 1-64 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K031856 | Preciset Tdm I and Preciset Tdm II Calibrators | Roche Diagnostics GmbH | DKB | Class II | |
| K031779 | Cadstream | Confirma, Inc. | LLZ | Class II | |
| K031706 | Cardioq, Model 9051-7005 | Deltex Medical Limited | DPW | Class II | |
| K031693 | Mallory/head Modular Calcar with and without Ha | Zimmer GmbH | LPH | Class II | |
| K031683 | Tox Ammonia Calibrator | Medrad, Inc. | JIX | Class II | |
| K031577 | Linical Protein 2 Calibration Verifiers Levels a-E for Beckman Coulter Array Protein Systems | Cliniqa Corporation | JJY | Class I | |
| K031539 | Hemoglobin A1c Reagent Set | Horiba Instruments Incorporated | LCP | Class II | |
| K031462 | The Nexgen Knee System Uncemented Components | Implex Corp. | MBH | Class II | |
| K031401 | Fixion Dynamic Hip Screw System (Fixion Dhs) | Disco-O-Tech Medical Technologies, Ltd. | KTT | Class II | |
| K031354 | Ebi Omega21 Spinal Fixation System | Ebi, LLC | MNI | Class II | |
| K030277 | Soft-Cell Dual Lumen Catheters | C.R. Bard Inc | MSD | Class II | |
| K030119 | Nanma Adjustable Constriction Ring | Nanma Mfg Co., Ltd. | LKY | Class II | |
| K032346 | Unity Network Is Patient Viewer | GE Medical Systems Information Technologies, Inc. | MSX | Class II | |
| K032336 | Tina-Quant Crp (Latex) | Roche Diagnostics GmbH | DCN | Class II | |
| K031915 | Pulpdent Etch-Rite Royale | Pulpdent Corporation | KLE | Class II | |
| K031830 | Safepro Plus Safety Syringe | Formosa Medical Devices, Inc. | MEG | Class II | |
| K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Cogentix Medical, Inc. | EOX | Class II | |
| K031775 | Preciset Dat Plus I Calibrators | Roche Diagnostics GmbH | DKB | Class II | |
| K031752 | Coltosol F | Coltene /Whaledent AG | EMA | Class II | |
| K031717 | Elecsys Shbg Immunoassay | Roche Diagnostics GmbH | CDZ | Class I | |
| K031472 | One Touch Basic/profile/one Touch II Test Strips | Lifescan, Inc. | CGA | Class II | |
| K031461 | Carrier Tips | Dentsply Intl. | ELC | Class II | |
| K031282 | Optilock Implantable Access Port, Model 1700-05 | LeMaitre Vascular Inc. | LJT | Class II | |
| K030795 | Lifesyne Systems | Gmp/Companies, Inc. | DRG | Class II | |
| K030219 | Digital Temperature Monitor; Model Ky-01 | Kang Ying Medical Appliances, Inc. | FLL | Class II | |
| K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card | Acon Laboratories, Inc. | DKZ | Class II | |
| K031574 | Squeeze-Ease Mammography Cushion | S & S X-Ray Products, Inc. | IZH | Class II | |
| K031435 | Bonesource Bvf | Howmedica Osteonics Corp | MQV | Class II | |
| K023548 | Proxis Flow-Control Device, Models Eps 101, Ic 101 | Velocimed, Inc. | DQY | Class II | |
| K023279 | Glucoleader Value | HMD Biomedical, Inc. | NBW | Class II | |
| K032202 | Dome Cx Digital Flat-Panel Display System, Models C2 and C5i | Planar Systems, Inc. | LLZ | Class II | |
| K032183 | Iq Hydrophilic Guide Wire | Boston Scientific Corporation | DQX | Class II | |
| K032128 | Terumo Al8x Arterial Filter with X-Coating | Terumo Cardiovascular Systems Corporation | DTM | Class II | |
| K032088 | Modification to Thermacool Tc System | Solta Medical, Inc. | GEI | Class II | |
| K031993 | Aurora Sr | Syneron Medical, Ltd. | GEX | Class II | |
| K031988 | Aurora Ds | Syneron Medical, Ltd. | GEX | Class II | |
| K031877 | Embrace Wet-Bond Restorative Material | Pulpdent Corporation | EBF | Class II | |
| K031851 | Dentiseptic Hpc | Bethel Co., Ltd. | EFB | Class I | |
| K031768 | Barrier-Pro Co-Polymer Patient Examination Glove, Powdered, White (Non-Colored) or Green Colored | Perusahaan Getah Asas Sdn. Bhd. | LZA | Class I | |
| K031707 | Sk Med M201 Plus Mixer | Sk Med | BZR | Class II | |
| K031641 | Vascular Architects Aspire Covered Stent and 718 Delivery System | Vascular Architects, Inc. | JCT | Class II | |
| K031625 | Powder-Free Barrier-Pro Co-Polymer Examination Glove, White (Non-Colored), and Green Colored | Perusahaan Getah Asas Sdn. Bhd. | LZA | Class I |