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 |
|---|---|---|---|---|---|
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical, Inc. | PML | Class II | |
| K221487 | NEOVEIL Staple Line Reinforcement | Gunze Limited | OXC | Class II | |
| K221212 | Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. | DXN | Class II | |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc | ODP | Class II | |
| K220819 | BrainsWay Deep TMS System | Brainsway Ltd. | OBP | Class II | |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | MedCAD | GXN | Class II | |
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics Inc. | PRI | Class II | |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) | Shanghai AnQing Medical Instrument Co., Ltd | FGB | Class II | |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros Ltd | FTL | Class II | |
| K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer | ConMed Corporation | GEI | Class II | |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | GZJ | Class II | |
| DEN210052 | Vibrant System | Vibrant Ltd | QTN | Class II | |
| K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | STERIS Corporation | NVE | Class II | |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | MXD | Class II | |
| K221792 | Acute QC Strut and Components | Smith & Nephew, Inc. | OSN | Class II | |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | LYY | Class I | |
| K221365 | LapBox Tissue Containment Removal System | Ark Surgical | GCJ | Class II | |
| K221325 | CONDUIT Lateral Switch Plate | Medos International SARL | MAX | Class II | |
| K221206 | Compass Steerable Needle | Serpex Medical, Inc. | KTI | Class II | |
| K221143 | Nitrile Exam Gloves (Blue, Black) | Hebei Astro Medical Supply Co.,Ltd | LZA | Class I | |
| K220055 | Disposable, vinyl examination gloves, Yellow | Dezhou Hengchang Medical Technology Co., Ltd. | LYZ | Class I | |
| K213905 | ONX Large External Fixation System | Orthonovis, Inc. | KTT | Class II | |
| K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | PBX | Class II | |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | Apex Biotechnology Corp. | NBW | Class II | |
| K211841 | MRI Planner | Spectronic Medical AB | MUJ | Class II | |
| K211298 | WiEMSpro | Medical Cables S.L. | NGX | Class II | |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology Inc | HQC | Class II | |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | Bard Access Systems, Inc. | LJS | Class II | |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health | Neuronetics Inc. | OBP | Class II | |
| K222212 | ivWatch Model 400 | Ivwatch, LLC | PMS | Class II | |
| K221920 | ARIX Small Fragment System | Jeil Medical Corporation | HRS | Class II | |
| K221427 | V-Laser | WONTECH Co., Ltd. | GEX | Class II | |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | Shenzhen Kentro Medical Electronics Co., Ltd | NUH | Class II | |
| K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | QKB | Class II | |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics Corp. | DRE | Class II | |
| K211771 | The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask | The Good Corporation | FXX | Class II | |
| K222274 | Fona Xdc | Fona S.R.L | EHD | Class II | |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | |
| K221850 | GMK 3D Metal Tibial Tray | Medacta International SA | MBH | Class II | |
| K221546 | OneTouch Delica Plus Lancing System | Asahi Polyslider Co., Ltd. | QRL | Class II | |
| K220640 | Bifix Hybrid Abutment Cement | Voco GmbH | EMA | Class II | |
| K220603 | Disposable Medical Safety Hypodermic Needle | Hantech Medical Device Co., Ltd. | FMI | Class II | |
| K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | IYE | Class II | |
| K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | Beijing Adss Development Co., Ltd. | GEX | Class II | |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | MEG | Class II | |
| K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | |
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | HBE | Class II | |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | Unclassified | |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp. | LIT | Class II | |
| K221604 | SafetiHeel, MediHeel, Novaplus | NSP Tech Pte Ltd | FMK | Class II |