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 |
|---|---|---|---|---|---|
| K080700 | Duoflo Catheter | Thermopeutix, Inc. | MJN | Class II | |
| K080017 | Vidas Afp Assay | bioMerieux, Inc. | LOJ | Class II | |
| K082636 | Txrx 15Ch Knee Coil (1.5T and 3T), Txrx Cp Extremity Coil 3T | Quality Electrodynamics | MOS | Class II | |
| K082449 | Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012 | Bisco Inc | EMA | Class II | |
| K082352 | Serim Disintek Opa Test Strip | Serim Research Corp. | JOJ | Class II | |
| K082319 | Injekt Filiform Injection Needle | Cook Incorporated | FBK | Class II | |
| K081985 | Aw Server | GE Healthcare | LLZ | Class II | |
| K081864 | Prolong | Life-Tech, Inc. | BSP | Class II | |
| K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | EIH | Class II | |
| K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | CBK | Class II | |
| K081503 | AED Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | GEI | Class II | |
| K081489 | L-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil Aneurysm Clip Appliers | Peter Lazic GmbH | HCH | Class II | |
| K081386 | Model 6150 (Mylab70) and Model 6100 (Mylab90) | Esaote S.p.A. | IYN | Class II | |
| K081236 | K-Y Brand Intrigue 2-in-1 Massage Creme | Mcneil-Ppc, Inc. | NUC | Class II | |
| K080602 | Audicor Sensor, Models: 2.0, 3.0 | Inovise Medical, Inc. | DRX | Class II | |
| K080164 | Zimmer Patient-Specific Ceramic Abutment | ZimVie US Corp LLC | NHA | Class II | |
| K072094 | Choostent | M.I.Tech Co Ltd | ESW | Class II | |
| K082736 | Radifocus Optitorque Angiographic Catheter | Terumo Medical Corp. | DQO | Class II | |
| K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene | Ceremed, Inc. | MTJ | Unclassified | |
| K082070 | Nuvasive Lateral Plate System | NuVasive Inc | KWQ | Class II | |
| K081883 | Modification to Preference Pedicle Screw System | Us Spine | MNH | Class II | |
| K081817 | Accell Tbm-R | IsoTis OrthoBiologics, Inc. | MBP | Class II | |
| K081800 | T12s Telemetry Transmitter | Mortara Instrument, Inc. | DQA | Class II | |
| K081442 | Heart Sync Pediatric, Model Ped-100 | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | LDD | Class II | |
| K081415 | Damon 4Clear | Ormco Corp. | NJM | Class II | |
| K081371 | Skintact Pediatric Multifunction Electrodes with Dh03 Gel | Leonhard Lang GmbH | MKJ | Class III | |
| K081363 | Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent Antimicrobial Alginate Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K080837 | Xpert Mrsa/sa Ssti Assay | Cepheid | NQX | Class II | |
| K080382 | Sellas | Dinona Co., Ltd. | GEX | Class II | |
| K082596 | Ultraextend Usws-900A | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K082453 | 4Cis Solar and Apollon Spine Systems | Solco Biomedical Corp. | MNH | Class II | |
| K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) | Medcomp | LJS | Class II | |
| K081472 | Smartport CT Vortex; Lp Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports | Boston Scientific Corporation | LJT | Class II | |
| K081443 | Menicon Z Rigid Gas Permeable Contact Lens | Menicon Co. Ltd. | HQD | Class II | |
| K081267 | Hygeia-5 Oxygen Concentrator | Kedl Internation Limited | CAW | Class II | |
| K082645 | Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (Ntp) Flex Reagent Cartridge, Model Rf623 | Siemens Healthcare Diagnostics Inc. | NBC | Class II | |
| K082228 | Planisight Linasys | Pathfinder Therapeutics, Inc. | LLZ | Class II | |
| K081743 | Classicstar Nv Se and Novastar Nv Se and Aav Full Face Masks | Draeger Medical AG & Co. KG | CBK | Class II | |
| K081514 | Tempo Cushion Treatment Denture Reline Acrylic Resin Liquid, Professional Size Package and Powder | Lang Dental Mfg Co, Inc. | EBI | Class II | |
| K081293 | Univation Unicondylar Knee System | Aesculap Inc | HRY | Class II | |
| K080803 | Visual Phacoemulsification System, Model 551 | Tenex Health | HQC | Class II | |
| K082659 | Modified Endo Stich | Covidien Lp, Formerly Registered AS United States | OCW | Class II | |
| K082459 | Acryderm Absorbent Oxygen Dressing | Acrymed, Inc. | FRO | Unclassified | |
| K082188 | Tympanostomy Tube | Acclarent Inc | ETD | Class II | |
| K081948 | Raypax System | Raypax, Inc. | LLZ | Class II | |
| K081779 | Golox-93 | Respironics, Inc. | BYJ | Class II | |
| K081730 | Novel Cervical Spinal Spacer System | Alphatec Spine, Inc. | ODP | Class II | |
| K081653 | Mdi Mii One-Piece Implant, 2.9Mm | Imtec Corp. | DZE | Class II | |
| K081639 | Icsi Cumulase | Medicult A/S | MQL | Class II | |
| K081602 | Dizzyfix | Clearwater Clinical Limited | LXV | Unclassified |