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 |
|---|---|---|---|---|---|
| K202431 | ControlRad Select Model Z | Controlrad, Inc. | OWB | Class II | |
| K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IZL | Class II | |
| K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab, Inc. | OLO | Class II | |
| K202237 | Locking device | Hangzhou AGS MedTech Co., Ltd. | ODC | Class II | |
| K202061 | Medical Face mask | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | FXX | Class II | |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | Plasdent Corp. | PEM | Class II | |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | GZJ | Class II | |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | AtriCure, Inc. | GXH | Class II | |
| K200631 | DeRoyal Temperature Monitoring Probe | DeRoyal Industries, Inc. | FLL | Class II | |
| K200610 | Customized Contour Implant | Implantech Associates Inc | FWP | Class II | |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies Ltd | KDI | Class II | |
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimer’s disease | Helix Opco, LLC | PTA | Class II | |
| DEN200016 | EndoRotor Device | Interscope, Inc. | QNE | Class II | |
| DEN190035 | Helix Laboratory Platform | Helix Opco, LLC | QNC | Class II | |
| K203552 | Rapid Reboot | Rapid Reboot Recovery Products | IRP | Class II | |
| K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K203476 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | |
| K203452 | Nano FortiFix® System | Nanovis, LLC | NKB | Class II | |
| K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement | ConforMIS, Inc. | JWH | Class II | |
| K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular | PNO | Class II | |
| K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X | Medphoton GmbH | OWB | Class II | |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Halyard Health | GXI | Class II | |
| K202974 | DenTek Fresh Protect Dental Guard | MedTech Products, Inc. | OBR | Unclassified | |
| K202968 | Da Vinci SP Surgical System | Intuitive Surgical, Inc. | NAY | Class II | |
| K202849 | Everyway Analog OTC TENS, model N103A/N302 | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K202820 | Australis Anterior Lumbar Cage System | Prism Surgical Designs Pty, Ltd. | MAX | Class II | |
| K202348 | External Remote Controller ERC 4P | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K202298 | Lucent XP, Lucent XP Curved | Spinal Elements, Inc | MAX | Class II | |
| K202229 | AI Metrics | Ai Metrics, LLC | LLZ | Class II | |
| K202211 | Disposable Medical Surgical Face Masks | Guangdong Kaidi Garments Co.,Ltd | FXX | Class II | |
| K202159 | actiTENS | Sublimed | GZJ | Class II | |
| K201910 | EZTrack | Neurologic, LLC | OLX | Class II | |
| K201707 | Opallis, Opallis Flow | Dentscare Ltda | EBF | Class II | |
| K201705 | ReVene Thrombectomy Catheter | Vetex Medical Limited | QEW | Class II | |
| K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | Choice Spine LLC | ODP | Class II | |
| K201491 | Neodent Implant System - Zirconia Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set | Argon Medical Devices, Inc | DYB | Class II | |
| K201287 | Impulse Interbody Fusion System | Degen Medical | MAX | Class II | |
| K201036 | PlaniMax Orthodontic Software | Choice Biotech, Inc. | PNN | Class II | |
| K200908 | iSMILE | 3D Diagnostix Inc | NXC | Class II | |
| K200473 | SoloAsisst II, Voice Control | AKTORmed GmbH | NAY | Class II | |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc | PLF | Class II | |
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra | Lode B.V. | ISD | Class II | |
| K202782 | num Vapocoolant | 623 Medical | MLY | Unclassified | |
| K201996 | Monocryl Plus Antibacterial Suture | Ethicon, Inc | GAM | Class II | |
| K201113 | Resascope RS-01/B | Advanced Medical Systems Group SRL | HRX | Class II | |
| K192308 | Wu's Electrical Scooter | Wu's Tech Co., Ltd. | INI | Class II | |
| K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (dba Tactile Medical) | JOW | Class II | |
| K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs Inc. | DSH | Class II | |
| K202668 | Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein | MEDLINE INDUSTRIES, LP - Northfield | KGO | Class I |