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 |
|---|---|---|---|---|---|
| K062760 | Ori F6t Dry ECG Monitoring Electrode | Orbital Research, Inc. | DRX | Class II | |
| K062602 | Band-Aid(r) Brand Liquid Bandage | Johnson & Johnson Consumer Companies, Inc. | KMF | Class I | |
| K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | KHJ | Class II | |
| K061875 | Minispir; Spirolab III | Mir Medical Intl. Research SRL | BZG | Class II | |
| K061533 | Proceed Ventral Patch | Ethicon, Inc | FTL | Class II | |
| K060694 | Modular Hybrid Glenoid | Biomet Manufacturing Corp | KWS | Class II | |
| K052509 | M-Bolus Embolic Microspheres | Scion Cardio-Vascular, Inc. | HCG | Class II | |
| K063366 | Microscan Synergies Plus Gram-Positive Mic/combo Panel with Synercid (0.12-2Ug/ml 5Dilution Breakpoint Sequence | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K063365 | Synergies Plus Gram-Positive Mic/combo Panels with Gentamicin (0.06-32Mg/ml Long Dilution Sequence | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K063334 | Shanghai Ganghai Model Giko 1400 | Shanghai Gangkai Purifying Products Co., Ltd. | MSH | Class II | |
| K063301 | Bd Phoenix Automated Microbiology System - Cefepime (Gn) 0.5-64Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K063237 | Theracal Lc | Bisco Inc | EJK | Class II | |
| K063228 | Surface Coat | Kuraray America, Inc. | EBD | Class II | |
| K063215 | Ever Light Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | |
| K063214 | Ever Light Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | |
| K063142 | Manual Pd-Io; Powered Pd-Io | Teleflex Medical | FMI | Class II | |
| K062997 | Arcomxl Polyethylene Liners and 38/40Mm Femoral Heads | Biomet Manufacturing Corp | LZO | Class II | |
| K062986 | Medtronic Graft Delivery Syringe | Medtronic Sofamor Danek USA Inc | FMF | Class II | |
| K062948 | Smart Gbs and Smartcycle Dx System and Software, Version 1.7B | Cepheid | NJR | Class I | |
| K062796 | K-Y Brand Intrigue | Personal Products Co. | NUC | Class II | |
| K062710 | Ge Datex-Ohmeda Engstrom Carestation | GE Healthcare | CBK | Class II | |
| K062707 | Rudolf Innoview Autoclavable Semi-Rigid Uretero-Renoscope | Innovative Endoscopy Components, LLC. | FGB | Class II | |
| K062367 | Miniscrews Anchoring System, M.a.s. | Micerium S.p.A. | DZE | Class II | |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories Inc. | LSE | Class I | |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories Inc. | LSE | Class I | |
| K061902 | Cosytherm, Models Ncm1, Ncm2, Ncb1, Ccu1, Cru1 | Inditherm Medical | DWJ | Class II | |
| K063460 | Acumed Congruent Bone Plate System | Acumed LLC | HRS | Class II | |
| K063416 | Luxvision Slit Lamp | U.S. Ophthalmic, L.L.C. | HJO | Class II | |
| K063254 | The Trufill Dcs Detachable Coil System; the Trufill Dcs Orbit Detachable Coil System | Cordis Neurovascular, Inc. | HCG | Class II | |
| K063200 | 20.1-Inch (51Cm) Color Lcd Monitor Cdl2010a (Ccl204) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K063153 | Novapacs | Novarad Corp. | LLZ | Class II | |
| K062794 | Prn Thermalcare, Model 3000 | American Healthcare Products Inc | DWJ | Class II | |
| K062752 | Mercator Microsyringe II Infusion Catheter | Mercator Medsystems, Inc. | KRA | Class II | |
| K062001 | Rostam Scented and Unscented Plastic Applicator Tampons | Rostam, Ltd. | HEB | Class II | |
| K061484 | Modification to: Smithwick Carotid Shunt | Mcpherson Enterprises, Inc. | DXC | Class II | |
| K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | OHT | Class II | |
| K063500 | Dc-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe | Grace Medical, Inc. | ETB | Class II | |
| K062915 | Veritas Collagen Matrix | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | Class II | |
| K062867 | Microlife Instant Digital Electronic Thermometer, Model Qt1jc1 | Microlife Intellectual Property GmbH | FLL | Class II | |
| K062709 | Powder Free Latex Examination Gloves, Black | P.T. Maja Agung Latexindo | LYY | Class I | |
| K062664 | Humidcare Heated Humidifier, Model 9S-004 | Apex Medical, Inc. | BTT | Class II | |
| K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA LLC | DZE | Class II | |
| K062364 | I-Scope 200 | Dongjin Medical Co., Ltd. | DQD | Class II | |
| K062324 | MRI Monitor with L-Cane05 and L-Cane05a Software and Module Options N-Psngv, N-Psng, N-Sngv, N-Sng, N-Psn, N-Sn | GE Healthcare | MHX | Class II | |
| K061844 | Dynasty Acetabular Shell and Cocr Acetabular Liner | Wrightmedicaltechnologyinc | JDL | Class III | |
| K061805 | Sta - Staclot Drvv Screen; Sta - Staclot Drvv Confirm | Diagnostica Stago, Inc. | GIR | Class I | |
| K061436 | Palomar Q-Yag 5 Nd:yag Laser System | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K061276 | G-Prox Endoscopic Grasper | Usgi Medical | GAT | Class II | |
| K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | KWS | Class II |