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 |
|---|---|---|---|---|---|
| K040905 | Wellness/jolivete | Tohkai Precision Ind., Ltd. | IRP | Class II | |
| K050191 | Modification to Bd Facscanto System with Bd Facscanto Clinical Software | Becton Dickinson & Co | PER | Class I | |
| K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | DQD | Class II | |
| K043572 | Compatibility ECG Trunk Cables | GE Healthcare | DSA | Class II | |
| K043444 | Multiple, Model Ktj-50 | Golden Horse Medical Equipment (Wuxi) Co., Ltd. | DXQ | Class II | |
| K043074 | Liberty System | Inovise Medical, Inc. | DPS | Class II | |
| K042768 | Medicompass Connect | Imetrikus, Inc. | DXN | Class II | |
| K042500 | Duopross Syringes | Duopross Meditech Corporation | FMF | Class II | |
| K042274 | Psd-60/Endoplasma | Olympus Shirakawa Co., Ltd. | GEI | Class II | |
| K031660 | Ferris Polymem Sterile Breast Pad | Ferris Mfg. Corp. | NTX | Class I | |
| K050314 | Aquinox | Abbott Medical | BTT | Class II | |
| K050290 | Lerado, Cosco | Lerado Oversea Ltd. Twn Branch (Bvi) | IOR | Class I | |
| K050282 | Modification to Tsrh Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K050228 | Agfa Heartlab Cardiovascular | Heartlab, Inc. | LLZ | Class II | |
| K050199 | Magnetom Symphony a Tim System | Siemens Medical Solution | LNH | Class II | |
| K050187 | Parietex Composite Pco-Os and Pco-Ob Meshes | Sofradim Production | FTL | Class II | |
| K050133 | D-Stat Radial Hemostatic Band | Vascular Solutions LLC | QSX | Unclassified | |
| K050078 | Roc Lumbar Plating System | Alphatec/Nexmed | MNH | Class II | |
| K050076 | Vitek 2 Gram Positive Ertapenem | bioMerieux, Inc. | LON | Class II | |
| K050023 | Secureloc; Advancintroducer | Specialized Health Products, Inc. | DYB | Class II | |
| K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 | Medtronic, Inc. | MCW | Class II | |
| K043551 | Datex-Ohmeda S/5 Psm Module, (Consisting of E-Psm and E-Psmp Modules) and Accessories | GE Healthcare | MHX | Class II | |
| K043490 | Pd-Io Disposable Intraosseous Infusion Needle | Teleflex Medical | FMI | Class II | |
| K043440 | Smith & Nephew, Inc. Revision Knee System | Smith & Nephew, Inc. | JWH | Class II | |
| K043439 | Infinity Modular Monitors with Vf5 Modifications (Delta/kappa/delta Xl/vista Xl/gamma X Xl and Sc 7000/8000/9000Xl | Draeger Medical Systems, Inc. | MHX | Class II | |
| K043351 | 4.5Mm Bone-Lok Facet Screw, Models Tfcd-45-3040S or N; Sfcd-45-3040S or N | Triage Medical, Inc. | MRW | Unclassified | |
| K043338 | Blakstone Laminoplasty Fixation System | Blackstone Medical, Inc. | NQW | Class II | |
| K043160 | Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/so | Tracoe Medical GmbH | JOH | Class II | |
| K043145 | Bi-Cortical Bio-Post and Washer, Model Ar-1367B | Arthrex GmbH | HTN | Class II | |
| K043142 | Inion Otps Biodegradable Mini Plating System | Inion Oy | HWC | Class II | |
| K043054 | Genie Magic Mix Ultra Hydrophilic Impression Material | Sultan Chemists, Inc. | ELW | Class II | |
| K042984 | Intergard Woven Connector Graft, Model Igw0030-10C | Intervascular, Inc. | DWF | Class II | |
| K042904 | Infinity Kappa Xlt | Draeger Medical Systems, Inc. | MHX | Class II | |
| K042683 | Well Lead Endotracheal Tube | Well Lead Medical Instruments | BTR | Class II | |
| K042600 | Stansion Matrix | Spineworks, LLC | MQP | Class II | |
| K031399 | Intergro Dbm | Interpore Cross Intl. | MQV | Class II | |
| K050363 | Fukuda Denshi Model Uf-850Xtd | Fukuda Denshi USA, Inc. | IYN | Class II | |
| K050117 | Modification to Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek | KWQ | Class II | |
| K050002 | Vitek 2 Compact | bioMerieux, Inc. | LON | Class II | |
| K043545 | Microscan Dried Gram-Positive Mic/combo Panels with Daptomycin (0.03 - 16 Mcg/ml) | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K043411 | Resofix Bioabsorbable Expansion Bolt | Resofix, Inc. | HTN | Class II | |
| K043379 | Shimadzu Surgical Mobile C-Arm Imaging X-Ray System, Model Wha-200 | Shimadzu Corp. | OXO | Class II | |
| K043100 | Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid Components | Zimmer GmbH | MBF | Class II | |
| K042957 | Durex Male Latex Condom with Warming Lubricant | Ssl Americas, Inc. | HIS | Class II | |
| K042928 | Modification to Global Spinal Fixation System | CG MedTech Co., Ltd. | MNH | Class II | |
| K042684 | Well Lead Tracheostomy Tube | Well Lead Medical Instruments | BTO | Class II | |
| K042553 | Biocardia Morph Universal Deflectable Guide Catheter | Biocardia, Inc. | DQY | Class II | |
| K042308 | Sheath-in-Sheath Catheter, 18Fr, Model S00018; Sheath-in-Sheath Catheter, 6 Fr., Model S00019 | Facile Medical, Inc. | DYB | Class II | |
| K050230 | Turbo Temp Trio | Cardinal Health, Alaris Products | FLL | Class II | |
| K050189 | Techtonix System | Howmedica Osteonics Corp | KWP | Class II |