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 |
|---|---|---|---|---|---|
| K000337 | Mtp Disposable Trocar Valves | Mtp Medical Technical Promotion GmbH | GCJ | Class II | |
| K000314 | Incentive Spirometer | Engineered Medical Systems, LLC | BWF | Class II | |
| K000275 | Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant Anesthesia | GE Healthcare | CAD | Class II | |
| K000127 | Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10 | Heinz Kurz GmbH Medizintechnik | MML | Class II | |
| K000125 | Jet Port Plus Catheter System | Clinical Plastic Products SA | LJT | Class II | |
| K000105 | Medtronic Extension Passer Tunneling System (38 Cm), Model 3555-38; Medtronic Extension Passer Tunneling System (60 Cm), | Medtronic, Inc. | GZF | Class II | |
| K000098 | Softline Spring Clip | Novare Surgical Systems, Inc. | DXC | Class II | |
| K000097 | Gsi 2000 Middle Ear Analyzer | Grason-Stadler, Inc. | ETY | Class II | |
| K990830 | Mallory/head Calcar Replacement with Interlocking Slots Bi-Metric Porous Collared Stem with Interlocking Slots | Zimmer GmbH | LPH | Class II | |
| K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, Lf140 Catheter Model 3040C | Possis Medical, Inc. | QEZ | Class II | |
| K000878 | Honigum | Dmg USA, Inc. | ELW | Class II | |
| K000777 | Samplok | Itl Corporation Pty, Ltd. | JKA | Class II | |
| K000768 | Wallach Quantum 500 Electrosurgical Generator | CooperSurgical, Inc. | EKZ | Class II | |
| K000471 | Future Diagnostics B.v. Stat-Intraoperative Intact Pth Kit | Future Diagnostics B.V. | CEW | Class II | |
| K000441 | Bodyguard | Vital Signs, Inc. | FMI | Class II | |
| K000415 | Ois-2500 Diagnostic Ultrasound System | Optimal Imaging Systems, Inc. | IYN | Class II | |
| K000350 | Screeners Cocaine Test; Drugscreen Dip Cocaine Test | Drug Detection Devices, Ltd. | DIO | Class II | |
| K000345 | Multi Purpose Flex Array Coil : Model 235 Series | Medical Advances, Inc. | MOS | Class II | |
| K000221 | Series 7700 Mobile C-Arm, Compact 7700 Mobile C-Arm, Compact 7700 Plus Mobile C-Arm | GE Dec Medical Systems | OWB | Class II | |
| K000198 | Cortek Arthroscope | Cortek Endoscopy, Inc. | HRX | Class II | |
| K000148 | Rgp Multi-Purpose Solution Id 100136 | Alcon Laboratories | MRC | Class II | |
| K994288 | 5.0Mm Spinal Screws | Ortho Tec, LLC | MNH | Class II | |
| K994062 | Hms Neuromuscular Stimulator | Home Medical Services | IPF | Class II | |
| K993867 | Bayer Advia Ims System | Bayer Corp. | CIG | Class II | |
| K993616 | Cardio-Card Interpretation System I | Nasiff Assoc., Inc. | LOS | ||
| K993448 | Stela Ut46 and Bt45/46 Straight Tined Pacing Leads, Stela Uj45 and Bj44/45 J-Shaped Tined Pacing Leads | Ela Medical, Inc. | DTB | Class III | |
| K993305 | Transluminal Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K993272 | Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System | Pure Water, Inc. | FIN | Class II | |
| K991458 | Meca Wrist Blood Pressure Meter, Model Ew243 and Model Ew254 | Matsushita Electric Corp. of America | DXN | Class II | |
| K000979 | Redi-Screen | Redwood Biotech, Inc. | LAF | Class II | |
| K000854 | Viridia Information Center Software for M3150a and M3153a, Viridia Telemetry System Transmitter | Agilent Technologies, Inc. | MHX | Class II | |
| K000845 | Modification to Jms A.v. Fistula Needle Set | JMS Co., Ltd. | FIE | Class II | |
| K000843 | Modification to Jms Apheresis Needle | JMS Co., Ltd. | FIE | Class II | |
| K000794 | Modification to Marspo2, Model 2001 | Novametrix Medical Systems, Inc. | DQA | Class II | |
| K000652 | Betel Powder Free Latex Exam Gloves, Chlorinated, with Protein Labeling Claim (50 Micrograms or Less) | Betel Care Sdn. Bhd. | LYY | Class I | |
| K000410 | Synchron Systems Alcohol Reagent and Calibrators | Siemens Healthcare Diagnostics Inc. | DMT | Class II | |
| K000321 | Hemisphere Modular Cup System | Ortho Development Corp. | LPH | Class II | |
| K000194 | Digital Inflection Rigidometer (Dir) | Uroan Xxi Electromedicina | LIL | Unclassified | |
| K000192 | E3 Microprob Series of Lasers and Accessories | Martin Uram, MD | GEX | Class II | |
| K000151 | Perry-Kolberg (Pk) Ha-Coated Titanium Sleeve | Integrated Orbital Implants Inc | MQU | Class II | |
| K000135 | Pro.duct Catheter, Model Cth03 | Pro. Duct Health, Inc. | KNW | Class II | |
| K994165 | Ontrak Teststik 3 for Cocaine/morphine/thc,cat. 1118595 | Roche Diagnostics GmbH | DIO | Class II | |
| K993923 | Adac Pinnacle3tm Radiation Therapy Planning System | Philips North America LLC | MUJ | Class II | |
| K993414 | Prucka Engineering Inc. Cardiolab Ep System,version 4.2 | Prucka Engineering, Inc. | DPS | Class II | |
| K992173 | Siphonguard Csf Control Device | Johnson & Johnson Professionals, Inc. | JXG | Class II | |
| K000935 | Kfa-63 Knee and Foot Array | Mri Devices Corp. | MOS | Class II | |
| K000934 | Mdi Scl-70 Test | Micro Detect, Inc. | LJM | Class II | |
| K000828 | Health-Plus, Sanitex, Reliance Pre-Powdered Laxtex Examination Glove | Pamitex Industries Sdn Bhd | LYY | Class I | |
| K000746 | Fukuda Denshi Dynascope, Model Ds-5800Nx | Fukuda Denshi USA, Inc. | DSI | Class II | |
| K000528 | Accuclot Drvvt Confirm, Catalog No. A62119 | Sigma Diagnostics, Inc. | GIR | Class I |