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 |
|---|---|---|---|---|---|
| K050797 | Tissu-Trans | Summit Medical, LLC | KYZ | Class I | |
| K050395 | Impedimed - Body Composition Analysis | Impedimed, Inc. | MNW | Class II | |
| K050381 | Cs Medical Ttcf Gas Delivery System | CS Medical LLC | BZR | Class II | |
| K050224 | 3Test Glucose Monitoring System | Neuero Engineering, Inc. | NBW | Class II | |
| K050135 | K-C Hemostatic Biopsy System | Bioengineering Consultants, Ltd. | FCG | Class II | |
| K051663 | Malibu Spinal System | Seaspine, Inc. | NKB | Class II | |
| K051588 | Biolox Delta Ceramic Femoral Heads | Howmedica Osteonics Corp | LZO | Class II | |
| K051550 | Inspiration Ventilator System | Event Medical Ltd | CBK | Class II | |
| K051465 | Powdered Latex Patient Examination Gloves | P.T. Anlis Abadi Internasional | LYY | Class I | |
| K051463 | Xeno Adhesive with Activator | Dentsply Intl. | KLE | Class II | |
| K051339 | R&d Cbc-4K Plus Retics Hematology Control | R & D Systems, Inc. | JPK | Class II | |
| K051311 | Microscan Synergies Plus Gram Positive Minimum Inhibitory Concentration/combo Panels - Levofloxacin | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. KGaA | CBK | Class II | |
| K051212 | Modification to Lncs Oximetry Sensors | Masimo Corporation | DQA | Class II | |
| K051147 | Sidekick Blood Glucose Test System | Home Diagnostics, Inc. | NBW | Class II | |
| K051124 | Zilver 635 Biliary Stent | Cook Inc. | FGE | Class II | |
| K051011 | Endosseous Dental Implant Abutment | Atlantis Components, Inc. | NHA | Class II | |
| K051009 | Huber Clear Safety Infusion Set | Now Medical Distribution, Inc. | FPA | Class II | |
| K050968 | Powderfree Polychloroprene Sterile Examination Gloves | PT. Medisafe Technologies | LZA | Class I | |
| K050592 | Somnomed Mas Rxa | Somnomed Inc. | LRK | Class II | |
| K050379 | Cs Medical Adult Ttcf Catheter | CS Medical LLC | BTO | Class II | |
| K043428 | Reliadent Dental Implant System | Bioinfera, Inc. | NHA | Class II | |
| K041696 | Rapid Reader | American Bio Medica Corp. | DKZ | Class II | |
| K051752 | Roche Elecsys Troponin T Stat (Short Turnaround Time) | Roche Diagnostics GmbH | MMI | Class II | |
| K051621 | Endoventions Alimaxx-E Esophageal Stent System | Alveolus, Inc. | ESW | Class II | |
| K051412 | Humeral Head Plate with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | HRS | Class II | |
| K051384 | Modification to: Nuvasive Neurovision Jjb System | NuVasive Inc | GWF | Class II | |
| K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | HWC | Class II | |
| K051272 | Bd Phoenix Automated Microbiology System - Clindamycin (Strep) 0.03125 -4 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K051155 | Solco 4Cis General Plate System | Solco Biomedical Corp. | HRS | Class II | |
| K051087 | Dimension Vista Integrated System | Siemens Healthcare Diagnostics Inc. | JJE | Class I | |
| K051068 | Zutron Colonoscope Stiffening Device | Zutron Medical | FDF | Class II | |
| K050960 | Modification to: Autodelfia Neonatal 17A-Oh-Progesterone L Kit | Wallac Oy | JLX | Class I | |
| K050887 | Gongdong Disposable Vaginal Speculum | Zhejiang Gongdong Medical Plastic Factory | HIB | Class II | |
| K050342 | Theralase Tlc-1000 Therapeutic Medical Laser System | Theralase Technologies Inc. | NHN | Class II | |
| K050053 | Hemoram/aggram Analyzer | Helena Laboratories, Corp. | JPA | Class II | |
| K043035 | Sepragel ENT Bioresorbable Packing/stent | Genzyme Corporation | KHJ | Class II | |
| K033579 | Reprocessed Multiple Clip Appliers | Clearmedical, Inc. | NMJ | Class II | |
| K033578 | Reprocessed Reloadable Cutters, Staplers, and Appliers | Clearmedical, Inc. | NLL | Class II | |
| K051668 | The Art of Intimacy Response Personal Lubricant | Goodmark USA, Inc. | NUC | Class II | |
| K051559 | Imask, Models 100, 200 and 300 | Vital Signs Colorado, Inc. | BZD | Class II | |
| K051530 | Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195. | American Medical Systems, Inc. | OTN | Class II | |
| K051518 | Unity Network Id | GE Medical Systems Information Technologies, Inc. | MWI | Class II | |
| K051262 | Esprit Ventilator Neonatal Option, Model V1000 | Respironics, Inc. | CBK | Class II | |
| K051108 | Piccolo Lactate Dephydrogenase Test System | Abaxis Inc | CFJ | Class II | |
| K050502 | Single Use Balloon Dilator Maxpasstm | Olympus Winter & Ibe GmbH | FGE | Class II | |
| K051717 | Rn Synocta Temporary Meso Abutment | Straumann USA, LLC | NHA | Class II | |
| K051624 | T2 Recon Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K051602 | Axiom Sireskop Sd | Siemens Medical Solutions USA, Inc. | JAA | Class II | |
| K051553 | Fuji Synapse Workstation Software | FUJIFILM Healthcare Americas Corporation | LLZ | Class II |