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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K173155 | Pakter Curved Needle Set | Cook Incorporated | BSP | Class II | |
| K173032 | Paxman Scalp Cooler | Paxman Coolers Limited | PMC | Class II | |
| K172909 | Elevare, Perfectio 4 | Omm Imports D/B/A Zero Gravity | OHS | Class II | |
| K172721 | Focal One | Edap Technomed Inc. | PLP | Class II | |
| K172121 | Digital Thermometer | Fudakang Industrial Co Ltd | FLL | Class II | |
| K181207 | Balego TENS Digital Edition with Accessories for Pain Relief (OTC) | Everyway Medical Instruments Co., Ldt. | NUH | Class II | |
| K181202 | Sentry IVC Filter | Novate Medical, Ltd. | DTK | Class II | |
| K180926 | uMR 560 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K180925 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | KTT | Class II | |
| K180712 | Coconut Infused Hybrid Personal Lubricant | United Consortium | NUC | Class II | |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | Cutera Inc | PBX | Class II | |
| K180672 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corp. | FRG | Class II | |
| K180621 | EchoMark, EchoMark LP | Sonavex, Inc. | NEU | Class II | |
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | Stryker Trauma GmbH | HSB | Class II | |
| K180427 | ARK Fentanyl Assay | Ark Diagnostics Inc | DJG | Class II | |
| K173053 | Powder Free Latex Examination Glove | Professional Latex Sdn Bhd | LYY | Class I | |
| K172780 | SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. | KNG | Class II | |
| K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 | Taidoc Technology Corporation | MWI | Class II | |
| K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | FRG | Class II | |
| K180608 | Lunoa System | Nightbalance BV | MYB | Class II | |
| K180593 | Vbeam Prima Laser System | Syneron Candela Corporation | GEX | Class II | |
| K180191 | SuperBall Meniscal Repair System | Arcuro Medical Ltd. | GAT | Class II | |
| K173961 | Straumann BLX Implant System | Straumann USA, LLC | DZE | Class II | |
| K173821 | LungQ Software | Thirona BV | JAK | Class II | |
| K173093 | TAMA BEMS device | Tama Research Corporation | NFO | Class II | |
| K173045 | Oximeter | Shenzhen Greatmade Tech Limited | DQA | Class II | |
| K172745 | ImmuGlo HEp-2 Elite IFA | Immco Diagnostics, Inc. | DHN | Class II | |
| DEN170089 | Curve Positive Airway Pressure System | Fresca Medical | QBY | Class II | |
| K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | NXO | Class II | |
| K180640 | SmartClip Soft Tissue Marker | Elucent Medical Inc | NEU | Class II | |
| K180500 | VariAx 2 System | Stryker Corp. | HWC | Class II | |
| K180447 | reVive Light Therapy LED Cleansing System | LED Technologies, Inc. | OLP | Class II | |
| K172807 | Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd | EZL | Class II | |
| K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | Zhejiang Kindly Medical Devices Co., Ltd. | JKA | Class II | |
| K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | Cook Incorporated | DYB | Class II | |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | KCI USA, Inc. | OMP | Class II | |
| K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | KPL | Class II | |
| K180617 | Hair Up | Y&j Bio Co., Ltd. | OAP | Class II | |
| K180325 | Single Use MultiClip Device | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | |
| K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster Inc | DQK | Class II | |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | GEI | Class II | |
| K180136 | BioNude Lubricant | Good Clean Love, Inc. | NUC | Class II | |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | LZG | Class II | |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | Applied Medical Technology Inc | KNT | Class II | |
| K173975 | UF(II) Wide Fixture | Dio Corporation | DZE | Class II | |
| K173330 | PanNAT STEC Test | Micronics, Inc. | PCI | Class II | |
| K172765 | Smart Moves Complete | Great Lakes Orthodontics, Ltd. | NXC | Class II | |
| K172499 | Neoshield | JMS North America Corp. | ONB | Class II | |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters | Abbott Medical | BSP | Class II |