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 |
|---|---|---|---|---|---|
| K200538 | Skeletal Dynamics Forearm Plating System | Skeletal Dynamics, Inc | HRS | Class II | |
| K200536 | 3MTM AttestTM Rapid 5 Steam-Plus Test Pack | 3M Complany | FRC | Class II | |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | GBM | Class II | |
| K193577 | SleepRight ProRx Custom Dental Guard | Splintek Inc. | OBR | Unclassified | |
| K193361 | ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical Inc. | CAC | Class II | |
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | HKI | Class II | |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Medtronic, Inc. | JOH | Class II | |
| K192864 | UNI*FUSE Infusion System with Cooper Wire | Boston Scientific Corporation | QEY | Class II | |
| K192601 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | |
| K191620 | Vitls Platform | Vitls, Inc. | DRG | Class II | |
| K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc | OLO | Class II | |
| K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | DQK | Class II | |
| K201172 | Cfp-3131, Cfp-2222 | Mx Imaging, Inc. | OWB | Class II | |
| K200920 | Idys ALIF ZP 3DTi | Clariance-SAS | MAX | Class II | |
| K200629 | Aspire Mechanical Aspirator G | Control Medical Technology | FMF | Class II | |
| K200511 | ROSA ONE Brain application | MedTech LLC | HAW | Class II | |
| K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics Inc. | MRG | Class II | |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | MQP | Class II | |
| K200002 | Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device | 4WEB Inc. | OVD | Class II | |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | LV Liberty Vision | KXK | Class II | |
| K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific, LLC | PNO | Class II | |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho | GAR | Class II | |
| K192262 | Dental Zirconia Blocks | De Corematrix Co., Ltd. | EIH | Class II | |
| K191334 | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 | Matia Robotics (US), Inc. | IPL | Class II | |
| K190982 | Automatic Digital Blood Pressure Monitor | Xiamen Ants Bro Technology Co., Ltd. | DXN | Class II | |
| K201131 | firefly T-2 | Firstkind Ltd | NGX | Class II | |
| K200979 | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | SeaSpine Orthopedics Corporation | KWQ | Class II | |
| K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K193665 | Frozen N | Yozma Bmtech Co., Ltd. | GEH | Class II | |
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | LifeCell Corp | MUU | Class II | |
| K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | Penumbra Inc. | QEW | Class II | |
| K192692 | Brainomix 360 e-CTA | Brainomix Limited | LLZ | Class II | |
| K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech(hangzhou)co.,Ltd | NFT | Class II | |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | Class II | |
| K200984 | Guardian Needle Electrode | Rhythmlink International, LLC | GXZ | Class II | |
| K200525 | Medical Diode Laser Hair Removal System | Weifang Mingliang Electronics Co.,Ltd. | GEX | Class II | |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K193336 | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | Synedgen, Inc. | OLR | Unclassified | |
| K193233 | Restoration® Modular Hip System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | |
| K192914 | Stimuplex Onvision System | Philips Medical Systems Nederland B.V. | BSP | Class II | |
| K192652 | Trv | Interacoustics a/S | LXV | Unclassified | |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | NDN | Class II | |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico | HQC | Class II | |
| K201130 | ACUSON Juniper Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | Medtronic, Inc. | GWM | Class II | |
| K201111 | GentleMax Pro Plus | Candela Corporation | GEX | Class II | |
| K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | NHJ | Class II | |
| K200944 | Uniexpert 2 Plus | Adani | KPR | Class II | |
| K200305 | NPseal | Guard Medical, Inc. | OKO | Class II |