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 |
|---|---|---|---|---|---|
| K933077 | Exeter Intramedullary Bone Plug | Howmedica Corp. | LZN | Class II | |
| K951914 | Hydracare Absorbent Wound Dressing | Acacia Laboratories, Inc. | KMF | Class I | |
| K951907 | Navarre Locking Pigtail Universal Drainage Catheter | Navarre Biomedical, Ltd. | GBX | Class I | |
| K951826 | Karl Storz Tracheal High Frequency Resectoscope | Karl Storz Endoscopy-America, Inc. | EOQ | Class II | |
| K951818 | Hichem Alt Reagent Kit | Hi Chem, Inc. | CKA | Class I | |
| K951749 | Bio-Lipid Lipid Control- Level 1,2 and 3 | Biocell Laboratories, Inc. | JJY | Class I | |
| K951748 | Coat-a-Count Lh Irma | Siemens Healthcare Diagnostics Inc. | CEP | Class I | |
| K951635 | Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator, Control | Beckman Instruments, Inc. | DEW | Class II | |
| K951586 | T-Uptake Eia Test | Diagnostic Reagents, Inc. | KHQ | Class II | |
| K951548 | Ace Amylase Reagent | Schiapparelli Biosystems, Inc. | JFJ | Class II | |
| K951427 | American Dental Products (Adp), Composite Restorative Material | American Dental Products, Inc. | EBF | Class II | |
| K951397 | Kodak X-Omat 5000 Ra Processor | Eastman Kodak Company | IXW | Class II | |
| K951396 | Kodak X-Omat 3000 Ra Processor | Eastman Kodak Company | IXW | Class II | |
| K951358 | Sireskop Sx | Siemens Medical Solutions USA, Inc. | JAA | Class II | |
| K951326 | Biopsy Device Accessory | Biopsys Medical, Inc. | BTA | Class II | |
| K951085 | Padgett Air Dermatome, Model a | Padgett Instruments, Inc. | GFD | Class I | |
| K950753 | Chakoff Endoscopy (Camera Television Endoscopic without Audio | Stephen Chakoff, Inc. | GCJ | Class II | |
| K950752 | Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire Accessory Kits | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K950751 | Tecothane 75D Polyurethane Resin for Pulse Generator Connector Modules | Medtronic, Inc. | DXY | Class III | |
| K950586 | Avd Intimax Thrombectomy Catheter | Applied Medical Resources Corp | DXE | Class II | |
| K950564 | Rich-Mar US-II Ultrasound | Rich-Mar Corp. | IMI | Class II | |
| K950524 | Nichols Institute Diagnostics Dhea-S Chemiluminescence Immunoassay | Nichols Institute | JKC | Class I | |
| K950420 | Fetalgard 3000 - Models Ip1, Ip2, Ap2 and Ap3 | Analogic Corp. | HGM | Class II | |
| K950270 | Nmi Software | Nicolet Biomedical, Inc. | OMB | Class II | |
| K950242 | Argus Arthroscopy Instrument System | Argus Medical Co., Inc. | HRX | Class II | |
| K950202 | Ringloc Constrained Liner | Zimmer GmbH | KWZ | Class II | |
| K950128 | Total Protein Test (Tpro) Item Xxxxx/r1. R2 | EMD Millipore Corporation | CEK | Class II | |
| K950110 | Mardx Mitochondria Eia Test System | Hogan & Hartson | LJM | Class II | |
| K950010 | Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated | Johnson & Johnson Professionals, Inc. | JWH | Class II | |
| K946228 | Cross Pin Screw System | Depuy, Inc. | JDW | Class II | |
| K946218 | Mardx Ena Eia Test System | Hogan & Hartson | LJM | Class II | |
| K946188 | Ccds Maestro(r) II Series 200 Cadiac Pacemaker | Cardiac Control Systems, Inc. | DXY | Class III | |
| K945614 | Add Power Family , Micro Addstat | Laserscope | GEX | Class II | |
| K945131 | Imagyn Intrauterine Insemination Device | Imagyn Medical, Inc. | HDR | Class II | |
| K945022 | Apofix Cervical Spine Fixation | Sofamor Co. | KWP | Class II | |
| K944684 | Polyscan Digital Scanner | Mse Medizintechnik GmbH & Co. KG | IYW | Class I | |
| K944280 | Transamerican Classic TENS | Transamerica Biomedical, Inc. | GZJ | Class II | |
| K943961 | The Model Acappella in the Ear Hearing Aid | Telex Communications, Inc. | ESD | Class I | |
| K943929 | Dataglove and Movement Analysis System (Mas) | Greenleaf Medical Systems, Inc. | KQX | Class I | |
| K943686 | Il Test Beta-2Microglobulin | Instrumentation Laboratory Co. | JZG | Class II | |
| K942346 | Imagert | Elekta Limited | IYE | Class II | |
| K926073 | Ultravac-Ng(tm) Nasogastric Sump Suction Tube | Surgimark, Inc. | FEG | Class II | |
| K925255 | Trax(tm) Cd4 Test Kit | T Cell Diagnostics, Inc. | GKZ | Class II | |
| K924306 | Percutaneous Endoscopic Gastrostomy | United States Endoscopy Group, Inc. | KNT | Class II | |
| K951912 | Disoposable & Resuable Monpolar Cord | Boston Surgical Products, Inc. | GEI | Class II | |
| K951847 | Avantgarde | Otto Bock Orthopedic Industry, Inc. | IOR | Class I | |
| K951715 | Endo Irrigator 2211, Including Tubing | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K951702 | Fms High Flow Arthro-Sheath | Future Medical Systems, Inc. | HNX | Class I | |
| K951695 | Operand* Ultrasound Transmission Gel | Redi Products, Inc. | IYN | Class II | |
| K951648 | Mist Endoscopic Needles | Mist, Inc. | FBK | Class II |