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 |
|---|---|---|---|---|---|
| K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | |
| K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corp. | LZO | Class II | |
| K213198 | Ax-Surgi Surgical Hemostat | Advamedica Inc. | POD | Class II | |
| K223685 | SmoothCool HR System | Jeisys Medical Inc. | GEX | Class II | |
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | JBP | Class II | |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | FYC | Class II | |
| K222907 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Rmkh Glove (Cambodia) Co., Ltd. | LZA | Class I | |
| K222483 | Surgical Face Mask | Hubei Woozon Healthcare Co., Ltd. | FXX | Class II | |
| K222221 | Deka Helix | El.en. Electronic Engineering SpA | GEX | Class II | |
| K222182 | Radial Artery Compression Tourniquets | Beijing Demax Medical Technology Co., Ltd. | DXC | Class II | |
| K222045 | Wearable Breast Pump (Model S1DW) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K221693 | Elecsys Anti-HCV II (08837031190) | Roche Diagnostics GmbH | MZO | Class II | |
| K221379 | Steriking LT-Blueline Pouches with Tyvek | Wipak Oy | FRG | Class II | |
| K221125 | SilentCloud | Aureliym GmbH | KLW | Class II | |
| K213263 | OnyxCeph | Image Instruments GmbH | LLZ | Class II | |
| K223775 | EZ-STIK Electrodes | South Dakota Partners | GXY | Class II | |
| K223378 | 3.0T 16ch AIR AA | GE Healthcare Coils (USA Instruments, Inc.) | MOS | Class II | |
| K222809 | Medical Disposable Face Masks | Anqing Mayfield Medical Limited | FXX | Class II | |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | KWS | Class II | |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | MQB | Class II | |
| K223616 | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | ODG | Class II | |
| K223605 | ControlSeal Electrode (ELSB) | Coapt LLC | GXY | Class II | |
| K222872 | DNA Appliance | Vivos Therapeutics Inc. | LRK | Class II | |
| K222767 | PeekMed web (v1) | Peek Health, S.A. | LLZ | Class II | |
| K222195 | aprevo® Digital Workflow | Carlsmed, Inc. | LLZ | Class II | |
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies Ltd | DQA | Class II | |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development LLC | OMB | Class II | |
| K221796 | Cyware 4H and Cysart 4H | Abys Medical | LLZ | Class II | |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | AtriCure, Inc. | OCL | Class II | |
| K214041 | Aesculap AICON Container | Aesculap Inc | KCT | Class II | |
| K213430 | Fingertip Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | DQA | Class II | |
| K213260 | CMFlexTM | Dimension Inx Corp. | LYC | Class II | |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Shanghai MicroPort EP MedTech Co., Ltd. | DRF | Class II | |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | Solta Medical, Inc. | GEX | Class II | |
| K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | JXG | Class II | |
| K223592 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific Corporation | FGE | Class II | |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | CIG | Class II | |
| K222984 | BioClean Implant Restorative System | Bioclean Dental, LLC | NHA | Class II | |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode | Well-Life Healthcare Limited | KPI | Class II | |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations SRL | MEG | Class II | |
| K221859 | Atalante | Wandercraft | PHL | Class II | |
| K221690 | Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R), Light Guide Adapter (Maj-1413) | Olympus Medical Systems Corp. | FAJ | Class II | |
| K221477 | AG100s | Hospitech Respiration | BSK | Class II | |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | Acumed LLC | HWC | Class II | |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App | Iren-Medical, Ltd. | FKX | Class II | |
| K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co., Ltd. | MHX | Class II | |
| K211557 | EndoPATx | Itamar Medical | DQK | Class II | |
| K223654 | Medussa-PL Cage | Medyssey USA | MAX | Class II | |
| K223286 | BD AutoShield Duo™ Pen Needle | Becton Dickinson & Co | FMI | Class II | |
| K222760 | StageOne™ Select Hip Cement Spacer Molds | Zimmer GmbH | MBB | Class II |