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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K233826 | Kosmos | Echonous Inc | IYN | Class II | |
| K220908 | Ensol EnTM Specimen Collection and Transport System | Ensol Biosciences, Inc. | JSM | Class I | |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | FMK | Class II | |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | SleepNet Corporation | CBK | Class II | |
| K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | MNU | Class II | |
| K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | GCJ | Class II | |
| K241557 | Cercon® yo ML | Dentsply Sirona Inc | EIH | Class II | |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho-Clinical Diagnostics, Inc. | LIP | Class II | |
| K241457 | Vista BC Putty | Inter-Med, Inc. | KIF | Class II | |
| K240545 | GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) | Genabio Diagnostics Inc | LZA | Class I | |
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences LLC | DXE | Class II | |
| K233827 | OxiWear | Oxiwear Inc | DQA | Class II | |
| K233816 | REDEMPTION Charcot Plating System | Vilex LLC | HRS | Class II | |
| K232991 | Bt-1000 | Bistos co., Ltd. | QGL | Class II | |
| DEN230067 | Chronos® | Germitec | SCS | Class II | |
| K242537 | BracePaste Fluoride Sealant | American Orthodontics | DYH | Class II | |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | DXT | Class II | |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Medrad, Inc. | NBW | Class II | |
| K241684 | Overjet Charting Assist | Overjet | QIH | Class II | |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Abbott Medical | FBK | Class II | |
| K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K241354 | Sealer Solvent | Inter-Med, Inc. | KJJ | Unclassified | |
| K241241 | Z1 Cemented Hip System | Orchard Medical Development | LZO | Class II | |
| K241228 | TENSWave | Zynex Medical Officer | GZJ | Class II | |
| K240270 | Electric wheelchair (S7018) | Guangdong Prestige Technology Co., Ltd. | ITI | Class II | |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | OCL | Class II | |
| K233846 | Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC | MQL | Class II | |
| K242044 | FiAPC plus probes | ERBE Elektromedizin GmbH | GEI | Class II | |
| K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | PKL | Class II | |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | IZQ | Class II | |
| K241777 | SmartAdjust™ Technology | Insulet Corporation | QJI | Class II | |
| K241607 | MyoStrain (6.0) | Myocardial Solutions | LNH | Class II | |
| K241538 | TriClip Steerable Guide Catheter | Abbott Medical | DQY | Class II | |
| K240982 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products Inc. | FXX | Class II | |
| K242264 | TMINI Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K242202 | LightWalker Laser System Family | Fotona d.o.o. | GEX | Class II | |
| K242191 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | |
| K242169 | Morph DNA Steerable Introducer Sheath | Biocardia, Inc. | DYB | Class II | |
| K241780 | Cardinal Health Nitrile Exam Gloves | Cardinal Health200, LLC | LZA | Class I | |
| K241492 | Guided Surgery Kit Cases | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K241302 | SonoSync | Samsung Medison Co., Ltd. | LLZ | Class II | |
| K240896 | ONE Nitrile Condom | Global Protection Corp. | MOL | Class II | |
| K240790 | Polyisoprene Surgical gloves | Suzhou Colour-way New Material Co., Ltd. | KGO | Class I | |
| K240593 | VEEGix EEG System | NeuroServo, Inc. | OLT | Class II | |
| K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | HRS | Class II | |
| K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation Corporation | GZB | Class II | |
| K233358 | SCoV-2 Ag Detect Rapid Test | Inbios International, Inc. | QVF | Class II | |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw | Proimtech Saglik Urunleri Anonim Sirketi | DZE | Class II |