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 |
|---|---|---|---|---|---|
| K071029 | Cardiodrive Catheter Advancement System (Cas) | Stereotaxis Inc | DQX | Class II | |
| K071010 | Tizian Ceramic, Flow, Plate, Fix & Zr Blanks | Schutz-Dental GmbH | EIH | Class II | |
| K070787 | Latitude Elbow Prothesis | TORNIER Inc. | JDB | Class II | |
| K061828 | Lorenz Biotech Aptiva, Version 2.13 | Lorenz Biotech S.p.A. | GZJ | Class II | |
| K072234 | Thermogard Xp Thermal Regulation System | Alsius Corp. | NCX | Class II | |
| K072220 | Pedi CO2 Easy | Westmed Inc | CCK | Class II | |
| K072207 | Duragen Xs Dural Regeneration Matrix | Integra LifeSciences Corporation | GXQ | Class II | |
| K072195 | Thromcat Thrombectomy Catheter System | DSM Biomedical, Inc. | MCW | Class II | |
| K071936 | Woundstat, Model Tc1001 | Traumacure, Inc. | QSY | Unclassified | |
| K071908 | Doctor's Light LED Dental Curing Light | Good Doctors Co., Ltd. | EBZ | Class II | |
| K070988 | Sc Profi Fine Pen Needle, Models; 5Mm, 8Mm, 12.7Mm (28G, 29G, 30G, 31G) | ShinChang Medical Co., Ltd. | FMI | Class II | |
| K070158 | R-Port Laparoscopic Access Device | Advanced Surgical Concepts | GCJ | Class II | |
| K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | HAW | Class II | |
| K062865 | Small Volume Syringe | Alcon Laboratories | FMF | Class II | |
| K072012 | Reflexion Spiral Variable Radius Catheter | Abbott Medical | DRF | Class II | |
| K071872 | Velashape | Syneron Medical, Ltd. | NUV | Class II | |
| K071703 | Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/drug And/or Biologic | Swiss American Products, Inc. | FRO | Unclassified | |
| K071686 | Powdered Vinyl Patient Examination Gloves | Langfang Huilong Plastic Product Co., Ltd. | LYZ | Class I | |
| K071648 | Extendsure Lyophilized Hba1c Linearity Controls | Canterbury Scientific Ltd. | JJX | Class I | |
| K071531 | Modification to Cyberknife Robotic Radiosurgery System | Accuray Incorporated | IYE | Class II | |
| K071422 | 15.5F Hemo-Stream Hemodialysis Catheter Set | Rex Medical LP | MSD | Class II | |
| K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II | |
| K071172 | Modified Merci Retriever, Model 90060 | Concentric Medical, Inc. | NRY | Class II | |
| K070962 | Coral Pedicle Screw System | Theken Companies LLC | NKB | Class II | |
| K070918 | 4Ddome | Cousin Biotech | FTL | Class II | |
| K062623 | Axiom Luminos Drf | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K072175 | Titanium Hip Tool Locking Plate | Orthopedic Sciences, Inc | HRS | Class II | |
| K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | EBG | Class II | |
| K071461 | Model 300D Home Oxygen Liquefier | Copd Partners, Inc. | CAW | Class II | |
| K071438 | Pss System | Spinal USA | MNI | Class II | |
| K070981 | Search Evolution (Lc) Total Knee System (Plasmapore) | Aesculap Inc | JWH | Class II | |
| K070780 | Conmed Linvatec Xo Button | Conmed Linvatec | MBI | Class II | |
| K070708 | Olympus Ft4-Free Thyroxine, Olympus T4- Total Thyroxine, Model# Osr210102, Osr210104 | Olympus Life & Material Science Europa GmbH (Irish | CEC | Class II | |
| K070185 | Tanda Skincare System, Plc-001, Tanda Blue, 414-001, Tanda Red, 660-001 | Pharos Life Corporation | GEX | Class II | |
| K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | GXZ | Class II | |
| K063190 | Silverseal Wound Packing Strips with X-Static | Noble Fiber Technologies, Inc. | QSY | Unclassified | |
| K072096 | Cbc-5D Plus Retics Hematology Control, Models: 5Dr03, 5Dr04 | R & D Systems, Inc. | JPK | Class II | |
| K072027 | Foru Kv10hb | Kwang Yang Motor Co., Ltd. | ITI | Class II | |
| K071822 | Urgent Pc Neuromodulation System, Models Upc200 and Upc250-12 | Uroplasty, LLC | NAM | Class II | |
| K071623 | Bd Phoenix Automated Microbiology System, Ampicillin-Sulbactam (Gn) 1/0.5-32/16 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K071380 | Modification to Solanas Posterior Stabilization System | Alphatec Spine, Inc. | NKB | Class II | |
| K071361 | R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005 | R4 Vascular, Inc. | LJS | Class II | |
| K071317 | Microscan Synergies Plus Gram Positive Mic/combo Panels New Antimicrobial-Gentamicin Synergy Screen | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K071316 | Microscan Synergies Plus Gram Positive Mic/combo Panels New Antimicrobial-Streptomycin Synergy Screen | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K071032 | Arthrex Univers II Shoulder Prosthesis | Arthrex GmbH | KWS | Class II | |
| K070376 | Conmed Linvatec 300W Xenon Light Source | Conmed Linvatec | GCT | Class II | |
| K072165 | Victory Three Wheel Scooter, Model: Sc610 | Pride Mobility Products Corp | INI | Class II | |
| K072131 | M3 Monitor | Spectrum Medical Inc | DRY | Class II | |
| K072104 | Heartway Power Mobility Scooter, Pf6 | Heartway Medical Products Co., Ltd. | INI | Class II | |
| K072089 | Arthrocare Spinewand | ArthroCare Corporation | GEI | Class II |