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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K150500 | Px PEEK IBF System | Innovasis, Inc | MAX | Class II | |
| K150419 | miraDry System MD4000 | miraDry, Inc. | OUB | Class II | |
| K150257 | PreludeEASE Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K150074 | Elevate Moisturizing Spray | Elevate Oral Care, LLC | LFD | Unclassified | |
| K143726 | Xlr8 Plus (Xlr8+) | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K143671 | Propeller Model 2014-D Sensor | Reciprocal Labs Corporation | CAF | Class II | |
| K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | DSH | Class II | |
| K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.net Software | Neurosoft Ltd | OLT | Class II | |
| K151356 | Spacemaker Pro Access and Dissector System | Medtronic, Inc. | GCJ | Class II | |
| K151276 | DePuy Synthes T-PAL Ti Spacer | Synthes (USA) Products LLC | MAX | Class II | |
| K151028 | LOGIQ e | GE Healthcare | IYN | Class II | |
| K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | OWB | Class II | |
| K150623 | Nanova Flowable Composite | Nanova Biomaterials Inc | EBF | Class II | |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder | Somnomed Inc. | PLC | Class II | |
| K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | Hebei Hongsen Plastics Technology Co, Ltd. | LZA | Class I | |
| K150113 | Fusion Black Powder-Free Nitrile Exam Glove | Halyard Health | LZA | Class I | |
| K150089 | NanoKnife System | Boston Scientific Corporation | OAB | Class II | |
| K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | OHT | Class II | |
| K142797 | I.V. Catheter | Jiangxi Sanxin Medtec Co.,Ltd. | FOZ | Class II | |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System | Zimmer Spine, Inc. | NKB | Class II | |
| K142596 | Infusomat Space Volumetric Infusion Pump | B.Braun Medical, Inc. | FRN | Class II | |
| DEN130039 | Brainport V100 Device | Wicab, Inc. | PIC | Class II | |
| K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | FZP | Class II | |
| K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | PHM | Class II | |
| K150920 | truFreeze System | CSA Medical | GEH | Class II | |
| K150727 | Estecem | Tokuyama Dental Corporation | EMA | Class II | |
| K150721 | ARDO Calypso Pro Powered Breast Pump | Ardo Medical AG | HGX | Class II | |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Co., Inc. | DXF | Class II | |
| K150667 | True Dilatation Balloon Valvuloplasty Catheter | C.R. Bard Inc | OZT | Class II | |
| K150512 | Star 90 | Skanray Technologies Pvt, Ltd. | MWI | Class II | |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis Inc | DXX | Class II | |
| K150119 | PALACOS R pro | Heraeus Medical GmbH | LOD | Class II | |
| K150018 | VS3-IR-MMS System | Visionsense, Ltd. | OWN | Class II | |
| K143622 | dynaMX Compression Staple | Mx Orthopedics, Corp. | JDR | Class II | |
| K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved | Medtronic, Inc. | EOQ | Class II | |
| K142898 | ABL800 FLEX with AQURE connectivity | Radiometer Medical ApS | CHL | Class II | |
| K142369 | Urinary Incontinence System | Guangzhou Finecure Medical Equipment Co.,Ltd | KPI | Class II | |
| K141879 | Belimed Steam Sterilizer Mst-H | Sauter AG | FLE | Class II | |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | ACell, Inc | FTM | Class II | |
| K140836 | Zibone Zirconia Blocks | Coho Technology Co., Ltd. | EIH | Class II | |
| K150882 | Edwards Suture Fastening System | Edwards Lifesciences LLC | HCF | Class I | |
| K150730 | Zimmer PSI Shoulder System | Zimmer GmbH | KWT | Class II | |
| K150719 | OARtrac System with Skin Sensors | Radiadyne | NZT | Class II | |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | ELC | Class II | |
| K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Co., Inc. | GEI | Class II | |
| K141919 | Veinoplus Sport Neuromuscular Stimulator | Ad Rem Technology SARL | NGX | Class II | |
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear | Yung Sheng Optical Co., Ltd. | MVN | Class II | |
| K150303 | XXL Vascular Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K150199 | Neodent Implant System | Jjgc Industria E Comercio de Materiais Dentarios S | DZE | Class II |