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 |
|---|---|---|---|---|---|
| K963976 | Immunochemistry Sys Urine Transferrin Reagent | Beckman Instruments, Inc. | DDG | Class II | |
| K963706 | Philips Sono Diagnost 800 | Hewlett-Packard Co. | IYO | Class II | |
| K963507 | Extra TENS (Ri-2500) Neo TENS (Ri-2000E) | Comtek Intl., Corp. | GZJ | Class II | |
| K963348 | Wallach Integration Unit | CooperSurgical, Inc. | HGI | Class II | |
| K963347 | Reusable, Adjustable, Magnetic PEEP Valve Be 142 | Instrumentation Industries, Incorporated | BYE | Class II | |
| K962141 | Volume Control Syringe Model Vcd-Syr-10 | B.Braun Medical, Inc. | DXT | Class II | |
| K961152 | Tuohy Epidural Needles | Hakko Shoji Co., Ltd. | BSP | Class II | |
| K961151 | Spinal Needles | Hakko Shoji Co., Ltd. | BSP | Class II | |
| K960842 | Latex Exam Glove with Hypoallergenic Labeling (Powdered) | Crocker Industrial Resources Sdn. Bhd. | LYY | Class I | |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | DYF | Class II | |
| K955461 | Transtracheal Catheter (Acc. Ravussin). | VBM Medizintechnik GmbH | BTO | Class II | |
| K953996 | Nikkiso Co, Ltd., Flx10gw, 12Gw, 15Gw, 18Gw & 21Gw Hemodialyzers | Nikkiso Co., Ltd. | KDI | Class II | |
| K953902 | Giotto High Tech (H.t.) Mammographic System | Medical Marketing Intl., Inc. | IZH | Class II | |
| K952910 | The Swirler Nebulizer | Amici, Inc. | CAF | Class II | |
| K952558 | Aaron Vac 2 | Apyx Medical Corporation | HKP | Class II | |
| K951728 | Schepens-Yoshida Video Binocular Indirect Ophthalmscope | Mira, Inc. | HLI | Class II | |
| K932221 | Neurological or Crani Trays (Packs) | Associated Medical Products Co. | LRO | Class II | |
| K970696 | S.p. 100 | Lsi Intl., Inc. | GZJ | Class II | |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(gem. 1050)/Estradiol Calibrators (Gem.c050) | Johnson & Johnson Clinical Diagnostics, Inc. | CHP | Class I | |
| K970613 | Patient Examination Gloves (Powder Free-Non Sterile) | Sti Medical Sdn Bhd | LYY | Class I | |
| K970467 | Ez Sure One Step Ovulation Predictor Home Test Kit | Excel Scientific, Inc. | CEP | Class I | |
| K970361 | Laser Eye Goggles | Stefanovsky & Assoc. | GEX | Class II | |
| K970359 | Combiprot Emergency Enfusion Device | B.Braun Medical, Inc. | LHI | Class II | |
| K970279 | Race Car Tympanometer with Audiometer(ae-Rcaud I/quik Tymp 1(Ae-Quik 1)/Quick Tymp 2(Ae-Quik 2) | American Electromedics Corp. | EWO | Class II | |
| K970151 | Interceptre Laparoscopic Instruments | Smith & Nephew, Inc. | HET | Class II | |
| K970017 | Nidek Cyberscan | Nidek, Inc. | GEX | Class II | |
| K965251 | Medtronic Algoline Intraspinal Catheter System | Medtronic, Inc. | MAJ | Class II | |
| K965142 | Vitros Immunodiagnostics Products Free T4 Reagent Pack (Gem.1015) Free T4 Calibrators (Gem.co15) | Johnson & Johnson Clinical Diagnostics, Inc. | CEC | Class II | |
| K965087 | Compat Gastrostomy/jejunostomy Feeding Tube Kit(088000) | Sandoz Nutrition | KNT | Class II | |
| K965076 | Mda Heparin Anti-X Assay | bioMerieux, Inc. | KFF | Class II | |
| K964946 | Sysmex Ca-1000/Sysmex Ca-5000 | Sysmex Corporation | JPA | Class II | |
| K964934 | Thrombonostika F1.2 | bioMerieux, Inc. | MIF | Class II | |
| K964889 | Elecsys Testosterone Assay | Boehringer Mannheim Corp. | CDZ | Class I | |
| K964875 | Cmv Antigen Control Slides | Viral Antigens, Inc. | GQH | Class II | |
| K964872 | Vzv Antigen Control Slides | Viral Antigens, Inc. | GQW | Class II | |
| K964870 | Rsv Antigen Control Slides | Viral Antigens, Inc. | GQG | Class I | |
| K964745 | Amsino Urinary Drainage Bag | Amsino Intl., Inc. | KNX | Class II | |
| K964524 | Ilt Argon Hp | Ion Laser Technology | EBZ | Class II | |
| K963446 | Kendall Dual Lumen Catheter | Kendall Healthcare Products Co. Div.Of Tyco Health | MPB | Class II | |
| K963268 | Genesis Rmp | Tecan U.S. | JRA | Class I | |
| K962628 | Moss Miami Spinal System | Depuy, Inc. | KWP | Class II | |
| K962408 | Nichols Advantage Chemiluminescence Free T4- Estimate Kit | Nichols Institute Diagnostics | CEC | Class II | |
| K970555 | Il0292 Dp Echoport | Smith | EWO | Class II | |
| K970155 | Neuro-Train II (2) | Sterne Equipment Co., Ltd. | IPF | Class II | |
| K970064 | Amicas Web/intranet Image Server | Autocyt Group, Inc. | LMD | Class I | |
| K970034 | Sd 800 Sonodiagnost Ultrasound Imaging System | Hewlett-Packard Co. | ITX | Class II | |
| K965203 | Radx System | E.M.S. - Electro Medical Systems SA | EHD | Class II | |
| K965193 | Liberty Anterior Spinal System | Sofamor Danek USA,Inc. | KWQ | Class II | |
| K965127 | Dgh Model 9000 | DGH Technology, Inc. | HQC | Class II | |
| K965101 | Cardiobeeper Cb-12L | Meridian Medical Technologies, Ltd. | DXH | Class II |