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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 | Fujimori Kogyo, Co., Ltd. | JOZ | Class II | |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Medical | JFP | Class II | |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems | GYC | Class II | |
| K200079 | ClearPoint System and Accessories | Mri Interventions, Inc. | HAW | Class II | |
| K193498 | Infinitt RT PACS | Infinitt Healthcare Co., Ltd. | LLZ | Class II | |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics Inc. | MOI | Class II | |
| K193472 | OrthoCircle Spine Pedicle Screw System | Orthocircle Spine | NKB | Class II | |
| K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology | Medtronic, Inc. | NEY | Class II | |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation | PGM | Class II | |
| K193168 | Agilon Moldable | Biogennix, LLC | MQV | Class II | |
| K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Canon Medical Systems Corporation | JAK | Class II | |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | Megagen Implant Co., Ltd. | NHA | Class II | |
| K192557 | Youjia Unscented Tampon with Plastic Applicators | Qingdao Youjia Hygiene Technology Co., Ltd. | HEB | Class II | |
| K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | NGT | Class II | |
| K192233 | LED Curing Light | Foshan CICADA Dental Instrument Co., Ltd. | EBZ | Class II | |
| K192158 | DiaTemp | Diadent Group International | EBG | Class II | |
| K192022 | DiaTemp Flow | Diadent Group International | EBG | Class II | |
| K191966 | NewPrim System | BRM Extremities SRL | KWH | Class II | |
| K191829 | Microlife Non-Contact Infrared Forehead Thermometer | Microlife Intellectual Property GmbH | FLL | Class II | |
| K191828 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | |
| K191689 | EleGARD Patient Positioning System | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | FOA | Class I | |
| K190909 | ArtiSential Bipolar Fenestrated Forceps | LivsMed Inc. | GEI | Class II | |
| K190882 | XenoSure Biologic Patch | LeMaitre Vascular Inc. | PSQ | Class II | |
| K183024 | Implacil Implant System | Implacil de Bortoli Material Odontologico Ltda | DZE | Class II | |
| K193178 | Biograph Horizon | Siemens Medical Solution USA, Inc. | KPS | Class II | |
| K191235 | Leltek Ultrasound Imaging System | Leltek Inc. | IYN | Class II | |
| K200182 | EzRay Air Portable (Model: VEX-P300) | Vatech Co., Ltd. | EHD | Class II | |
| K193013 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K192596 | ULab Systems Dental Aligner Kit | uLab Systems, Inc | NXC | Class II | |
| K192165 | Acteon Imaging Suite | De Gotzen S.r.l. | LLZ | Class II | |
| K191453 | Cervitec F | Ivoclar Vivadent, Inc. | LBH | Class II | |
| K191202 | Capenergy - C100, C200, C300, C400, C50 | Capenergy Medical, S.L. | PBX | Class II | |
| K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International SA | NKG | Class II | |
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems Inc | OCC | Class II | |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | Sutter Medizintechnik GmbH | GEI | Class II | |
| K193165 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | MBI | Class II | |
| K193156 | Arthrex Mini Comprehensive Fixation System - 1.0mm Screws | Arthrex GmbH | HWC | Class II | |
| K192846 | Argen Clear Aligner, Argen Clear Aligner Premium | The Argen Corporation | NXC | Class II | |
| K192841 | InPen System | Companion Medical, Inc. | NDC | Class II | |
| K192749 | Dermadry | Dermadry Laboratories Inc. | EGJ | Class II | |
| K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. | IYE | Class II | |
| K192203 | JO for Him H2O Gel Original Personal Lubricant | United Consortium | NUC | Class II | |
| K191919 | Elos Accurate Hybrid Base | Elos MedTech Pinol a/S | NHA | Class II | |
| K190192 | K3Pro Konus New Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft mbH CO KG | DZE | Class II | |
| DEN190038 | Surfacer Inside-Out Access Catheter System | Bluegrass Vascular Technologies, Inc. | QJH | Class II | |
| K200117 | Trevo NXT ProVue Retriever | Stryker Corp. | POL | Class II | |
| K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge Pack | 3M Company | FRC | Class II | |
| K193129 | Yukon OCT Spinal System | K2M, Inc | NKG | Class II | |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Revvity Health Sciences, Inc. | NQL | Class II | |
| K192527 | Rochal Antimicrobial Wound Gel | Rochal Industries, LLC | FRO | Unclassified |