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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K011749 | Latex Powdered Patient Examination Glove, 200 Micrograms or Less | Sempermed USA, Inc. | LYY | Class I | |
| K011604 | Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MRI | GE Healthcare | LNI | Class II | |
| K011073 | Cryoplan System | Cryomedical Sciences, Inc. | GEH | Class II | |
| K010418 | Dried Gram-Negative and Gram-Positive Mic/combo Panels | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K010372 | Lightlas 532 Photocoagulator | Lightmed Corp. | HQF | Class II | |
| K001853 | Syringe Management System, Model Sms-1 | Medtech Systems, Inc. | FMI | Class II | |
| K012422 | K-Assay D-Dimer Controls | Kamiya Biomedical Company, LLC | GGC | Class II | |
| K012104 | Snow Lotus Powder-Free Latex Surgeon's Gloves | Beijing Reagent Latex Products Co., Ltd. | KGO | Class I | |
| K012038 | Jas Uric Acid Liquid Reagent | JAS Diagnostics/Drew Scientific | KNK | Class I | |
| K012020 | Respievents Software Is Event Data Processing Sofware for a Pc | Non-Invasive Monitoring Systems, Inc. | DQK | Class II | |
| K011991 | Modification to Medrad Spectris Mr Injector | Medrad, Inc. | DXT | Class II | |
| K011660 | Weck Cardiac Pacing Wires | Weck Closure Systems | LDF | Class II | |
| K010785 | Ksea Dion-Gracia Set | Karl Storz Endoscopy-America, Inc. | DXC | Class II | |
| K012478 | Modification to: I-Stat Portable Clinical Analyzer | I-Stat Corp. | CHL | Class II | |
| K012451 | Propaq Encore Models 202, 204, 206; Propaq Cs Models 242, 244, 246 | Welch Allyn Protocol, Inc. | DRT | Class II | |
| K012312 | Immulite 2000 Tobramycn, Models L2ktc2 (2002 Tests), L2ktc6 (600 Tests) | Siemens Healthcare Diagnostics Inc. | KLB | Class II | |
| K012311 | Immulite 2000 Gentamicin, Models L2kge2 (200 Tests), L2kge6 (600 Tests) | Siemens Healthcare Diagnostics Inc. | LCD | Class II | |
| K012295 | Human Igg Subclass Liquid Reagent Kits, Product Code Nk001.t | The Binding Site | CFN | Class II | |
| K012291 | Human Igg Subclass Liquid Reagent Kits, Product Code Lk001.ta | The Binding Site | CFN | Class II | |
| K012276 | Temp 3 | Medical Solutions, Inc. | LGZ | Class II | |
| K012243 | Mcc Uricheck Assayed Liquid Urine Multiconstituent Control | Hematronix, Inc. | JJY | Class I | |
| K012163 | Polytiter System | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC | DHN | Class II | |
| K012122 | Validate Chem 5 Calibration Verification Test Set, Model 10005 | Maine Standards Co. | JJX | Class I | |
| K012120 | Validate Chem 4 Calibration Verification Test Set, Model 10004 | Maine Standards Co. | JJY | Class I | |
| K012119 | Validate Chem 3 Calibration Verification Test Set, Model 10003 | Maine Standards Co. | JJY | Class I | |
| K012118 | Validate Chem 2 Calibration Verification Test Set, Model 10002 | Maine Standards Co. | JJY | Class I | |
| K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001 | Maine Standards Co. | JJY | Class I | |
| K012058 | Stat Profile Phox Plus L Analyzer | Nova Biomedical Corporation | CHL | Class II | |
| K012053 | Diamedix Is-Anti-Cardiolipin Screen Test System | Diamedix Corp. | MID | Class II | |
| K011339 | Quest Exercise Stress System, Model Configuration 14 | Spacelabs Burdick, Inc. | DSI | Class II | |
| K011333 | Cercon Ceram | Degussa - Ney Dental, Inc. | EIH | Class II | |
| K010755 | Bayer Diagnostics Advia Centaur Toxoplasma Igm Assay | Bayer Corp. | LGD | Class II | |
| K010635 | Interlok / Ha Copeland Resurfacing Heads | Zimmer GmbH | MBF | Class II | |
| K012553 | Gsibp Blood Pressure Cuff | Globalshop, Inc. | DXQ | Class II | |
| K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K012455 | Welch Allyn Durashock Blood Pressure System | Welch Allyn Inc | DXQ | Class II | |
| K012280 | Titanium Compression Anchor System Model Version 2 | Triage Medical, Inc. | HWC | Class II | |
| K012216 | Niroyal Biliary Premounted Stent System | Boston Scientific Corporation | FGE | Class II | |
| K011575 | 22Mm Siteselect Breast Biopsy Device Model Ssd022 | Imagyn Surgical | KNW | Class II | |
| K010735 | Speedybell | Biopsybell S.A.S. | KNW | Class II | |
| K003552 | Iti Dental Implant System | Straumann USA, LLC | DZE | Class II | |
| K012444 | Abn Aneroid Sphygmomanometer | Pt. Sugih Instrumendo Abadi | DXQ | Class II | |
| K012379 | Pdx-2000 Portable Digital X-Ray System | Trex Enterprises Corp. | IZL | Class II | |
| K012242 | Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | FJK | Class II | |
| K012156 | Imagine H.e. | Wieland Edelmetalle GmbH & Co. | EIH | Class II | |
| K012048 | Powder Free Neoprene Examination Gloves, Non Sterile | WRP Asia Pacific Sdn Bhd | LZA | Class I | |
| K011801 | Futura Topcap Non Gamma-2 | Ab Ardent | EJJ | Class II | |
| K011784 | Modification to Envoy Patient Monitor | Mennen Medical, Inc. | DSI | Class II | |
| K011765 | Sunmax Blue Nitrile Powder-Free Examination Glove | Sunmax Enterprise Shanghai Co., Ltd. | LZA | Class I | |
| K011667 | Horizons International Polypectomy Snares | Horizons Intl. Corp. | FDI | Class II |