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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II | bioMerieux, Inc. | LYR | Class I | |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | ELITechGroup Inc | JIX | Class II | |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Mri Interventions, Inc. | HBG | Class II | |
| K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | FOZ | Class II | |
| K150480 | JO H20 Water Based Personal Lubricant | United Consortium | NUC | Class II | |
| K150423 | Expazen | Produits Dentaires Pierre Rolland (Acteon Group) | MVL | Unclassified | |
| K150301 | NavSuite3 Kit | Stryker Leibinger GmbH & Co. KG - Navigation | HAW | Class II | |
| K143607 | I-Portal NOTC, VNG and VOG | Spryson America Inc | GWN | Class II | |
| K142970 | SterilContainer S System | Aesculap Inc | KCT | Class II | |
| K151543 | Graft Delivery Device with Integrated Stylet | Micromedics, Inc. (D/B/A Nordson Medical) | FMF | Class II | |
| K151530 | CardioChek Plus Test System | Polymer Technology Systems | CGA | Class II | |
| K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix SRL | NKB | Class II | |
| K151438 | Dentrix Ascend Imaging | Realcloud Imaging, Inc. | LLZ | Class II | |
| K151233 | Monaco | Elekta Limited | MUJ | Class II | |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System | PENTAX of America, Inc. | GEH | Class II | |
| K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | KLE | Class II | |
| K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | Ellipse A/S | GEX | Class II | |
| K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe Inc. | JDW | Class II | |
| K143202 | ANGIO-PRESS DVT Compression Device Model Name: IPCS | Pegasus Medical Supply, Inc. | JOW | Class II | |
| K143070 | Disposable Safety Self-destructive Syringes, 5 ML | Jiangsu Yile Medical Article Co., Ltd. | MEG | Class II | |
| K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | KLA | Class II | |
| K142705 | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics, Inc. | DOF | Class II | |
| K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory Co. | DAP | Class II | |
| K151317 | Armada 18 PTA Catheter | Abbott Vascular | LIT | Class II | |
| K151197 | Lariat snare | United States Endoscopy Group, Inc. | FDI | Class II | |
| K150995 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | NUH | Class II | |
| K150632 | Hypervisor IX Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MSX | Class II | |
| K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | FUJIFILM Healthcare Americas Corporation | FDF | Class II | |
| K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | Medtronic, Inc. | GCJ | Class II | |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | DSP | Class II | |
| K151170 | Tosama 100% Organic Cotton Menstrual Tampon | TOSAMA d.o.o. | HEB | Class II | |
| K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | DQK | Class II | |
| K150935 | SpeediCath Compact Eve | MEDLINE INDUSTRIES, LP - Northfield | GBM | Class II | |
| K150872 | BruxZir Anterior Milling Blanks | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K150784 | Admira Fusion | Voco GmbH | EBF | Class II | |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | EGS | Class I | |
| K150712 | LTM-Perforated Surgical Mesh | LifeCell Corp | FTM | Class II | |
| K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | Ethicon, Inc | NEW | Class II | |
| K150477 | 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization | 3M Company | JOJ | Class II | |
| K150296 | Biodenta Customized Abutment-Hybrid | Biodenta Swiss AG | NHA | Class II | |
| K150039 | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | Arthrex GmbH | MBI | Class II | |
| K143236 | Theranos Herpes Simplex Virus-1 IgG Assay | Theranos, Inc. | MXJ | Class II | |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience Inc | CDZ | Class I | |
| K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit | Care Fusion | DWM | Class II | |
| K140762 | Automatic Blood Pressure Monitor | Jawon Medical Co., Ltd. | DXN | Class II | |
| K151497 | EN Snare Endovascular Snare System | Merit Medical Systems, Inc. | MMX | Class II | |
| K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | DJG | Class II | |
| K151147 | STARband, STARlight | Orthomerica Products, Inc. | OAN | Class II |