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 |
|---|---|---|---|---|---|
| K083189 | Steri-Lub Lubrication Gel | Avail Medical Products, Inc. | KMJ | Class I | |
| K083146 | Asahi Regalia Xs 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K083125 | Neuron Select Catheter Size 070 | Penumbra Inc. | DQY | Class II | |
| K083048 | Neoray Dr 2520 Digital Imaging System | Portavision Medical, LLC | IZL | Class II | |
| K082604 | Viztek Dr, Models: Dr1000, Dr3000, Dr4000 | Viztek, LLC | KPR | Class II | |
| K082553 | Rexastom Oral Ease | Rexaderm, Inc. | OLR | Unclassified | |
| K082508 | Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard | Branan Medical Corp. | DJG | Class II | |
| K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K082441 | Nordicice Software | Nordicimaginglab AS | LLZ | Class II | |
| K082432 | Core Vision Digital Specimen Radiography (Dsr) System | Bioptics, Inc. | MWP | Class II | |
| K082349 | Jarit Hulka Uterine Tenaculum Forceps | J. Jamner Surgical Instruments, Inc. | HDC | Class II | |
| K082125 | N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700Pft | Best Glove, Inc. | LZA | Class I | |
| K081713 | Vertebral Access System by Vidacare | Teleflex Medical | MOQ | Class I | |
| K081460 | Tds Abutment | Pou YU Biotechnology Co., Ltd. | NHA | Class II | |
| K081287 | Sapphire Plasma Arc Dental Curing Light | Den-Mat Holdings, LLC | EBZ | Class II | |
| K081080 | Tsrh Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K081025 | Isoelasticu | Remi Sciences, Inc. | KXE | Class II | |
| K080430 | Stoma Bone Block Screw | Storz AM Mark GmbH | DZL | Class II | |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-Controls | Diasorin Inc. | LFX | Class II | |
| K072664 | Ge Lunar Femur Strength Software | GE Medical Systems Ultrasound and Primary Care Dia | KGI | Class II | |
| K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836 | Medtronic Neurosurgery | JXG | Class II | |
| K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Inc | LZO | Class II | |
| K082990 | Infinitt Xelis | Infinitt Co., Ltd. | LLZ | Class II | |
| K082628 | Cmr42 Cardiac MRI Imaging System, 2.1.23 | Circle Cardiovascular Imaging Inc | LLZ | Class II | |
| K082579 | Evercross .035 Otw Pta Dilatation Catheter | Medtronic, Inc. | DQY | Class II | |
| K082538 | Bd Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test | Becton Dickinson & Co | LON | Class II | |
| K082339 | Enabler-P Support Catheter | Endocross, Ltd. | DQY | Class II | |
| K082299 | Vericore Implant Abutments | Whip-Mix Corp. | NHA | Class II | |
| K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | JCT | Class II | |
| K082240 | Sntrypacs | Qstar Technologies, Inc. | LLZ | Class II | |
| K082205 | Factor VIII Antibody Screen | Immucor GTI Diagnostics, Inc. | GGP | Class II | |
| K083100 | Goldadapt Non-Engaging Nobelactive Np & Rp, Goldadapt Engaging Nobelactive Np & Rp | Nobel Biocare USA LLC | NHA | Class II | |
| K082851 | Multlink Cable and Leadwire System | GE Medical Systems Information Technologies, Inc. | DSA | Class II | |
| K082773 | Standard Imaging Imsure Brachy Qa Software, Model 91331 | Standard Imaging Inc. | IYE | Class II | |
| K082714 | Audit Microcv Therapeutic Drug (Tdm) Linearity Set, Model K707m-5 | Aalto Scientific Ltd. | JJY | Class I | |
| K081505 | Theragem Professional T1002 | Medica Health, Ltd. | ILY | Class II | |
| K081380 | Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 Mm Bone Screws | K2M, Inc | KWQ | Class II | |
| K081313 | Sh14 Hemoconcentrator | Corcym Inc. | KDI | Class II | |
| K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | FGE | Class II | |
| K072634 | EMG Triton -Comp,model Nca01-Xxx Series | EMG Technology Co., Ltd. | BTI | Class II | |
| K083227 | Vida Pulmonary Workstation 2 (Pw2) | Vida Diagnostics | JAK | Class II | |
| K082907 | Ic-Pro System, Version 3.1.0.4 | Paieon, Inc. | IZI | Class II | |
| K082650 | Synthes Large External Fixation, Mr Conditional | Synthes (USA) Products LLC | KTT | Class II | |
| K082500 | Depuy Sigma Cr-F Femoral Component | Depuy Orthopaedics Inc. | JWH | Class II | |
| K082354 | Stereo Navigator Accessory, Stn-1000 | CMR Naviscan Corporation | KPS | Class II | |
| K082348 | Fibernet Embolic Protection System | Lumen Biomedical, Inc. | NTE | Class II | |
| K082347 | Digital Radiography, Flexdr C30 | Konica Minolta Technoproduct Co., Ltd. | MQB | Class II | |
| K082276 | Synthemed Device | Synthemed Corp. | LYA | Class I | |
| K081940 | Avalon Elite Vascular Access Kit | Avalon Laboratories, LLC | DRE | Class II | |
| K081685 | Liaison Hsv-1 Type Specific Igg Assay, Control Hsv-1 Igg | Diasorin Inc. | MXJ | Class II |