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 |
|---|---|---|---|---|---|
| K213299 | Wireless EEG System | Pascall Systems Inc | OLT | Class II | |
| K213177 | Plus Medical Cover Gown | Foshan Nanhai Plus Medical Co Ltd | FYA | Class II | |
| K213001 | Procedure Mask, Surgical Mask | A Plus International, Inc | FXX | Class II | |
| K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips | Macromedics BV | IYE | Class II | |
| K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | HIS | Class II | |
| K221136 | RadiForce MX243W | Eizo Corporation | PGY | Class II | |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | ConforMIS, Inc. | JWH | Class II | |
| K220727 | inHEART MODELS | Inheart, SAS | LLZ | Class II | |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K220428 | Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | |
| K220427 | White Nitrile Powder-Free Patient Examination Glove, Non Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | |
| K214008 | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | NVK | Class II | |
| K213004 | Needle Free Connector | Medcaptain Life Science Co., Ltd. | FPA | Class II | |
| K212519 | Overjet Caries Assist | Overjet | MYN | Class II | |
| K210585 | Bd Ctgctv2 | Becton Dickinson & Co | QEP | Class II | |
| K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Co., Inc. | DYB | Class II | |
| K213946 | Compass BDS Biliary Stent | Cook Ireland Ltd. | FGE | Class II | |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | Cefla S.C. | EBW | Class I | |
| K211840 | Sight OLO | S.D. Sight Diagnostics, Ltd. | GKZ | Class II | |
| K203527 | Immunalysis Tapentadol Urine HEIA | Lmmunalysis Corporation | DJG | Class II | |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | NJR | Class I | |
| K221046 | Invu by Nuvo | Nuvo- Group, Ltd. | LQK | Class II | |
| K220689 | Vatech Clismile | Rayence Co., Ltd. | NJM | Class II | |
| K220664 | NewTom 7G | Cefla S.C. | JAK | Class II | |
| K220653 | Astroglide Glycerin & Paraben Free | Biofilm, Inc. | NUC | Class II | |
| K220269 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Spectrum Medical Inc | DTR | Class II | |
| K214108 | Medline Orbis Chemo Surgical Gown | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | |
| K213975 | KEOPS Balance Analyzer 3D | S.M.A.I.O | LLZ | Class II | |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems LLC | OVD | Class II | |
| K213900 | WAVi SCAN EEG System and Accessories | WAVi Co. | GWQ | Class II | |
| K213884 | Disposable EEG cable | Shenzhen Changke Connect Electronics Co., Ltd. | GXY | Class II | |
| K213788 | TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) | Dongguan Bohuikang Technology Co.,Ltd | NUH | Class II | |
| K212657 | Quantum Heater-Cooler | Spectrum Medical Inc | DWC | Class II | |
| K212582 | SpyGlass Discover Balloon Dilation Catheter | Boston Scientific Corporation | GCA | Class II | |
| K212564 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | |
| K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC | Medtronic, Inc. | DQA | Class II | |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | Neuronetics Inc. | QCI | Class II | |
| K212092 | Portable Folding Electric Wheelchair (Model: DC01) | Anhui JBH Medical Apparatus Co., Ltd | ITI | Class II | |
| K211966 | Segment 3DPrint | Medviso AB | LLZ | Class II | |
| K211685 | Elecsys Testosterone II | Roche Diagnostics GmbH | CDZ | Class I | |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | FGE | Class II | |
| K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | NBW | Class II | |
| K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular | LIT | Class II | |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | DRA | Class II | |
| K221016 | Steriking Packaging for Medical Devices | Wipak Oy | FRG | Class II | |
| K221013 | GIA Auto Suture Stapler with DST Series Technology | Medtronic, Inc. | GDW | Class II | |
| K220716 | Spartan SC 069 | Spartan Micro, Inc. | DQY | Class II | |
| K220691 | LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension | Seigla Medical, Inc. | DQY | Class II |