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 |
|---|---|---|---|---|---|
| K193592 | Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K193213 | Vicks VNT200 No Touch Forehead Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | |
| K192498 | Single Use Injector | Olympus Medical Systems Corp. | FBK | Class II | |
| K192197 | Magicore II System | Innobiosurg Co., Ltd. | DZE | Class II | |
| K200624 | Percutaneous Introducer | Epimed International, Inc. | BSO | Class II | |
| K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K200533 | binx io CT/NG Assay and binx io CT/NG System | Binx Health, Inc. | QEP | Class II | |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics Inc. | HKI | Class II | |
| K200208 | Agape Warming Personal Lubricant | CC Wellness LLC | NUC | Class II | |
| K200141 | Oxi-W System | LD Technology LLC | MWI | Class II | |
| K200101 | WOLF Thrombectomy V System | Devoro Medical, Inc. | QEW | Class II | |
| K193459 | Panther Stereotactic | Prowess, Inc. | MUJ | Class II | |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K193350 | Leadtek Fingertip Pulse Oximeter | Leadtek Research, Inc. | DQA | Class II | |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | KKX | Class II | |
| K192834 | MECTA Sigma | Mecta Corporation | QGH | Class II | |
| K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | Microport Orthopedics Inc. | LZO | Class II | |
| K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | MJN | Class II | |
| K192068 | i-ED COIL | Kaneka Pharma America, LLC | HCG | Class II | |
| K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | JWH | Class II | |
| K200397 | Single Use Biopsy Forceps FB-456D | Olympus Medical Systems Corp. | EOQ | Class II | |
| K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International SARL | NKB | Class II | |
| K200074 | O-arm O2 Imaging System | Medtronic, Inc. | OWB | Class II | |
| K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K193153 | SPIRA-C Integrated Fixation System | Camber Spine Technologies | OVE | Class II | |
| K193033 | GSI Audera Pro | Grason-Stadler, Inc. | GWJ | Class II | |
| K192856 | MT One | M&T SRL | GEX | Class II | |
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | KDL | Class II | |
| K192063 | PGDx elio tissue complete | Personal Genome Diagnostics Inc. | PZM | Class II | |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | GWQ | Class II | |
| K190139 | Zircos-Com | Bioden Co., Ltd. | EBF | Class II | |
| K200847 | Surgical Face Mask | Mexpo International, Inc. | FXX | Class II | |
| K200787 | Bsd3543w | Bontech Co., Ltd | MQB | Class II | |
| K200762 | CoLink Cfx Plating System | In2bones USA, LLC | HRS | Class II | |
| K200705 | Nurochek System | Cryptych Pty, Ltd. | GWE | Class II | |
| K200666 | Stryker Xia 3 Power Adaptor | Howmedica Osteonics Corp | NKB | Class II | |
| K200444 | Biomonitor III, Biomonitor IIIm | BIOTRONIK AG | MXD | Class II | |
| K200167 | QuikClot Control+ | Z-Medica, LLC | POD | Class II | |
| K200070 | ARx Spinal System | Life Spine | NKB | Class II | |
| K193305 | DynaClip Bone Staple | Medshape, Inc. | JDR | Class II | |
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | Medical Components, Inc. | MPB | Class II | |
| K192644 | GM501 SpermAir and GM501 SpermActive | Hamilton Thorne Incorporated | MQL | Class II | |
| K192475 | NemoFAB | Software Nemotec, S.L. | LLZ | Class II | |
| K192358 | Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd | IRP | Class II | |
| K192230 | Mf Safecath | Medifirst Co.,Ltd. | FOZ | Class II | |
| K192183 | RocaTub Ureteral Catheter | Promepal Sam | EYB | Class II | |
| K191308 | U-Aligner | Universal Orthodontic Laboratory, Inc. | NXC | Class II | |
| K200771 | Indigo Aspiration System Lightning Aspiration Tubing | Penumbra Inc. | QEW | Class II |