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 |
|---|---|---|---|---|---|
| K012744 | Intraoral Lens Option to Spectroshade | Mht Optic Research AG | EIA | Class I | |
| K011967 | Bd Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe | BD | FOZ | Class II | |
| K011757 | Exel Comfortpoint Insulin Pen Needle | Exelint Intl. Co. | FMI | Class II | |
| K011625 | Vasocor Vascular Diagnostic Center (Model 300) | Vasocor, Inc. | DXN | Class II | |
| K010923 | Kion Anaesthesia System, Model 65 03 879 E392e | Siemens Elema AB | MHX | Class II | |
| K020028 | 6F Mach1/34356-Xxx; 5F Mach1/35845-Xxx; 7F Mach1/34357-Xxx; 8F Mach1/34358-Xxx | Boston Scientific Corporation | DQY | Class II | |
| K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | ETN | Class II | |
| K014134 | Powder-Free Latex Exam Gloves with Protein Labeling (<50Ug/g) | Supergrade Healthcare Products Sdn. Bhd. | FMC | Class I | |
| K013898 | R&d Ret-Line Kit | R & D Systems, Inc. | JPK | Class II | |
| K013858 | Infinion 0.6T Mr Imaging System | Philips North America LLC | LNH | Class II | |
| K013857 | Aimstep Pregnancy | Germaine Laboratories, Inc. | DHA | Class II | |
| K013795 | Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs, Green Color | Shen Wei (USA), Inc. | LYY | Class I | |
| K013794 | Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs | Shen Wei (USA), Inc. | LYY | Class I | |
| K013793 | Powder Free Latex Examination Gloves with Aloe Vera @Ph 5.5 and Protein Labeling Claims | Shen Wei (USA), Inc. | LYY | Class I | |
| K013769 | V-Gnathos Supra | Metalor Technologies USA | EJT | Class II | |
| K013738 | Weinmann Somnomask | Gottlieb Weinmann Geraete Fuer Medizin und Arbeits | BZD | Class II | |
| K013620 | Medstone, Uropro 2000, Tomographic Option | Medstone Intl., Inc. | IZF | Class II | |
| K013595 | Premier III Phased Array Ctl Spine Coil | GE Healthcare Coils | MOS | Class II | |
| K013594 | Body Array Coil | GE Healthcare Coils | MOS | Class II | |
| K013578 | Pump Tubing | Terumo Cardiovascular Systems Corporation | DWE | Class II | |
| K013465 | Accu-Base Hemoglobin A1c Sample Collection Kit | Diabetes Technologies, Inc. | LCP | Class II | |
| K013262 | Polymer Coated Powder Free Latex Examination Gloves | Great Glove (Thailand) Co., Ltd. | LYY | Class I | |
| K013163 | Uniglove Lano-E Powder-Free Latex Examination Gloves | N.S. Uni-Gloves Sdn. Bhd. | LYY | Class I | |
| K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex | Crosstex Intl. | FXX | Class II | |
| K012480 | Vanguard Reprocessed Inflation Devices | Stryker Sustainability Solutions | MAV | Class II | |
| K012398 | Diomed 15 Diode Laser | Diomed, Inc. | GEX | Class II | |
| K992099 | Bio Spa Intelligent | Starbene | IPF | Class II | |
| K014222 | Arthrocare Controller, Patient Cable, Foot Control, Power Cord | ArthroCare Corporation | GEI | Class II | |
| K014209 | Padpro Model 2001, 2001-S, 2001-C, 2001-Eps | Padpro, LLC | MKJ | Class III | |
| K014184 | Modification to Dynalink .035 Biliary Self-Expanding Stent System | Boston Scientific Corporation | FGE | Class II | |
| K014159 | Phillips M1175a/76a/77a Component Monitoring System; Phillips V24/v26 Patient Monitor | Philips North America LLC | DSI | Class II | |
| K013912 | Creatine Kinase (Ck-Nac) | JAS Diagnostics/Drew Scientific | CGS | Class II | |
| K013894 | Tansmit/receive Quadrature Body Coil 3.0T | Philips North America LLC | MOS | Class II | |
| K013783 | Aution Max Ax-4280 Urinalysis System | International Remote Imaging Systems | KQO | Class I | |
| K013771 | Modification to: Winner Cm-2 Muscle Stimulator, TENS, Therapeutic Ultrasound and Combination Device | Rich-Mar Corp. | IPF | Class II | |
| K013770 | Modification to: Winner St-2 Stimulator | Rich-Mar Corp. | IPF | Class II | |
| K013750 | Advia 1650 Cholinesterase Assay | Bayer Diagnostics Corp. | DIH | Class I | |
| K013685 | Plla Cannulated Interference Screw | Future Medical Systems, Inc. | HWC | Class II | |
| K013535 | Evtool Model # V. 1.0 | 3D Line USA, Inc. | MUJ | Class II | |
| K013533 | Ems Telemedicine Option (for Gems Series 4000) | General Devices | DRG | Class II | |
| K013518 | Embryo Freeze Medium, Embryo Thaw Medium | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K013510 | Point 4 Modified | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K013494 | 3.75Mm and 5.0Mm Spline Twist Implant | Sulzer Dental, Inc. | DZE | Class II | |
| K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | JOJ | Class II | |
| K013165 | USA Series Laparoscopes | Circon Acmi | GCJ | Class II | |
| K013155 | Dade Thromboplastin C Plus | Siemens Healthcare Diagnostics Inc. | GJS | Class II | |
| K013128 | N Latex Lp(a) | Siemens Healthcare Diagnostics Inc. | DFC | Class II | |
| K013116 | Durq/ Qualidura | Ever-Safety Technical Service | BTA | Class II | |
| K012943 | The Quantech Fastraq Automated Analyzer, and the Quantech Prepaq Total Hcg Test Cartridge | Quantech, Ltd. | NAL | Class II | |
| K012684 | Reprocessed Electrosurgical Electrode | Sterilmed Inc | JOS | Class II |