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 |
|---|---|---|---|---|---|
| K960095 | Bactidrop Calcofluor White | Remel Inc | JTS | Class I | |
| K960090 | Calcofluor White Stain Kit | Remel Inc | JTS | Class I | |
| K960005 | Tri-Court 20-T | Hematronix, Inc. | JPK | Class II | |
| K955353 | One Step Pregnancy Hcg Serun Diluent Reagent | Tcpi, Inc. | JHI | Class II | |
| K955022 | Quanta Lite Mpo | Inova Diagnostics, Inc. | MOB | Class II | |
| K955021 | Quanta Lite Pr3 | Inova Diagnostics, Inc. | MOB | Class II | |
| K954974 | Pace Saver Little Junior (Modification) | Burke Mobility Products | INI | Class II | |
| K954159 | Digital Imaging System | Camtronics, Ltd. | LLZ | Class II | |
| K954124 | O-Perm 30 a Rigid Gas Permeable Contact Lens | Optical Polymer Research, Inc. | HQD | Class II | |
| K954105 | Eia Kit for the Detction of Anti-Pr3 Antibodies | Scimedx Corp. | MOB | Class II | |
| K954062 | Eia Kit for the Detection of Anti-Mpo Antibodies | Scimedx Corp. | MOB | Class II | |
| K945302 | Sloan Sta-Dri Pant Protector | Sloan Corp. | LYU | Class I | |
| K940048 | Stc Diagnostics Pcp Micro-Plate Eia Modification | Solarcare Technologies Corp,Inc. | DLJ | Class II | |
| K936240 | Sudormed Sweat Patch Speciment Container (Phencyclidine) | Sudormed, Inc. | JKA | Class II | |
| K960526 | Primidone Eia Test | Diagnostic Reagents, Inc. | DJP | Class II | |
| K960411 | Microair by Invacare Model Apm Alternating Pressure Air Flotation Matress | Invacare GmbH | FNM | Class II | |
| K960023 | Kirshner Wires (K-Wire) & Steinmann Pins | Promex, Inc. | JDW | Class II | |
| K960014 | Practifix External Fixation System | Orthopaedic Innovations, Inc. | KTT | Class II | |
| K955843 | Tas Ptone | Cardiovascular Diagnostic Services | GJS | Class II | |
| K955234 | Trupeak Peak Flow Meter | Monaghan Medical Corp. | BZH | Class II | |
| K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | DQK | Class II | |
| K960878 | Mahler Abdominal Wall Elevator | Cook Incorporated | GCJ | Class II | |
| K960547 | Dimension Penta/dimension Garant L/polyvinyl Siloxane Adhesive | Espe GmbH & Co. KG. | ELW | Class II | |
| K960480 | In-Ceram Spinell Kit for Celav Model V56-001/E63013 | Vident | ELL | Class II | |
| K960340 | Consensus Apex Dome Hole Plug | U.S. Medical Products, Inc. | JDI | Class II | |
| K960317 | Laurus Needle Core Biopsy System | Laurus Medical Corp. | FCG | Class II | |
| K960270 | Dentalogic | Protecs Syringes International Corp. | EJI | Class II | |
| K960219 | Prolex Mesh | Advanced Surgical Innovations, Inc. | FTL | Class II | |
| K960165 | Alpha-Dent Composite Surface Sealant | Wallace A. Erickson & Co. | EBF | Class II | |
| K960112 | Kis Mt5 | Implant Center of the Palm Beaches | DZE | Class II | |
| K955942 | Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | IYO | Class II | |
| K955864 | J.b. S. C1-C2 Clamp | J.B.S., S.A. | KWP | Class II | |
| K955833 | Niomed Surgical Caps | Amerasia Corp. | FYF | Class I | |
| K955774 | Varis Portalvision | Varian Assoc., Inc. | IYE | Class II | |
| K955722 | Flexon Temporary Cardiac Pacer Lead | Davis & Geck, Inc. | LDF | Class II | |
| K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | CAW | Class II | |
| K955281 | Endosseous Dental Implant & Accessories | Straumann USA, LLC | DZE | Class II | |
| K954487 | Pre Powdered Latex Examination Gloves | Ganz Industries Sdn. Bhd. | LYY | Class I | |
| K954467 | Cadplan Bt | Varian Assoc., Inc. | JAQ | Class II | |
| K954172 | X-Ray Visions | Image Visions, LLC | LMD | Class I | |
| K953835 | Lilliput 1 New Born Hollow Fiber Oxygenator | Dideco S.p.A. | DTZ | Class II | |
| K953752 | Rt55 Diagnostic Ultrasound System | General Electric Co. | IYO | Class II | |
| K951261 | Dfi-1000 and Dvs-475 Imaging Devices | Nical | JAA | Class II | |
| K951185 | Nexgen Complete Knee Solution 9Mm Articular Surface | Zimmer GmbH | JWH | Class II | |
| K946277 | Tetrad 2300 e/u Ultrasoung Imaging System | Tetra Corp. | IYN | Class II | |
| K945849 | Frialit(r)-2 Stepped Cylinder with Frios(r) Ti-Coating | Friatec Medical Inc., USA | DZE | Class II | |
| K945848 | Frialit(r)-2 Dental Implant | Friatec Medical Inc., USA | DZE | Class II | |
| K945847 | Frialit(r)-2 Stepped Screw with Deep Profile Surface | Friatec Medical Inc., USA | DZE | Class II | |
| K960469 | Detect Cytology Brush II | Cook Incorporated | HHT | Class II | |
| K960203 | G.e. Sterile Amniocentesis Tray | GE Healthcare | HIO | Class I |