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 |
|---|---|---|---|---|---|
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | FDF | Class II | |
| K213506 | NB 1 SA Implant System | ARUM DENTISTRY Co., Ltd. | DZE | Class II | |
| K210714 | Extended Reservoir | Medtronic, Inc. | LZG | Class II | |
| K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | MNR | Class II | |
| K203783 | ClariPulmo | Claripi Inc. | LLZ | Class II | |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apex Biotechnology Corp. | NBW | Class II | |
| K202106 | Plasmage System | Brera Medical, Inc. | GEI | Class II | |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | |
| K220335 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K214081 | MRCAT Head & Neck | Philips Oy | MUJ | Class II | |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream | Co-Innovation Biotech Co.,Ltd. | LCX | Class II | |
| K213783 | Apyx | Escala Medical | PBQ | Class II | |
| K213746 | Digital thermometer, Model DT101, DT102 | Guangzhou Berrcom Medical Device Co., Ltd | FLL | Class II | |
| K213560 | Verifine Safety Syringe with Fixed Needle | Promisemed Hangzhou Meditech Co.,Ltd. | FMF | Class II | |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci.&tech.co.,Ltd. | FXX | Class II | |
| K213011 | Infrared Thermometer (model: E201) | Bioland Technology Ltd. | FLL | Class II | |
| K212601 | DRPx Locking Distal Radius Plate System | The Orthopaedic Implant Company | HRS | Class II | |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | Geistlich Pharma AG | NPL | Class II | |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) | Taidoc Technology Corporation | FLL | Class II | |
| K220022 | TRATE Dental Implant System | Trate AG | DZE | Class II | |
| K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Boston Scientific Corporation | QEZ | Class II | |
| K213282 | ERI Handheld Dental X-ray System (Model AG100) | Energy Resources International Co., Ltd. Hsinchu Branch | EHD | Class II | |
| K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune.Ai, Co., Ltd. | QIH | Class II | |
| K212126 | MediExpand Cervical Expandable VBR System | CMF Medicon Surgical Inc | PLR | Class II | |
| K220066 | Medical Nitrile Examination Gloves | Hunan Zhenheyikang Medical Instrument Co., Ltd. | LZA | Class I | |
| K213604 | ELAZ Nitrile Powder Free Examination Glove | Protect Gloves Co., Ltd. | LZA | Class I | |
| K220343 | Nitrile Examination Gloves | Nb Medical Co., Ltd. | LZA | Class I | |
| K212947 | Trinity Plus Wrinkle Reducer | Carol Cole Company dba NuFACE | OHS | Class II | |
| K220668 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K220601 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | |
| K220518 | Skanrad 400 | Skanray Technologies Limited | KPR | Class II | |
| K220151 | MAGNETOM Avanto Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K220005 | TENS & PMS Unit | Shenzhen Yuehua Xinsen Technology Co., Ltd. | NUH | Class II | |
| K213793 | EMPOWR Revision Knee | Encore Medical, LP | JWH | Class II | |
| K213657 | Deepvessel Ffr | Keyamed Na, Inc. | PJA | Class II | |
| K213552 | PuraStat-RM | 3-D Matrix, Inc. | PHN | Unclassified | |
| K213494 | Aveir Retrieval Catheter | Abbott Medical | MMX | Class II | |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K213432 | MIS Angulated multi-unit abutments | Dentsply Sirona Inc | NHA | Class II | |
| K213118 | Dakota ALIF System | Precision Spine, Inc. | OVD | Class II | |
| K212392 | Intri24 Sheath | Inari Medical, Inc. | DYB | Class II | |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | KDI | Class II | |
| K212184 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | |
| K211882 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | NWB | Class II | |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Thayer Medical Corportation | NVP | Class II | |
| K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) | Saneso, Inc. | FDF | Class II | |
| K220678 | APX-24 Portable X-ray System | Aspenstate, Inc. | IZL | Class II | |
| K220674 | TargetCool | Recensmedical Inc. | GEH | Class II |