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 |
|---|---|---|---|---|---|
| K100846 | Imc Surgical Face Mask | Intl. Medsurg Connection, Inc. | FXX | Class II | |
| K100588 | Human Iga2 Kit for Use on the Spaplus | The Binding Site Group Ltd. | CFN | Class II | |
| K090947 | 21.3 (54 Cm) Monochrome Digital Mammography Lcd Monitor, Model Ms3112 (Mdl2128a) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K102149 | Gaunying Infrared Lamp | Foshan Gaunying Electronics Co., Ltd | ILY | Class II | |
| K102037 | Autosure Voice II Blood Glucose Monitoring System and Test Strips | Apex Biotechnology Corp. | CGA | Class II | |
| K101623 | Inquiry Afocusii Diagnostic Catheter | Abbott Medical | DRF | Class II | |
| K101390 | Fastpack Tsh Immunoassay | Qualigen Inc | JLW | Class II | |
| K101150 | Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | DYB | Class II | |
| K100786 | Microthermx Microwave Ablation System, Models Mtx-180 or Mtx | Bsd Medical Corp. | NEY | Class II | |
| K100179 | Spaplus | The Binding Site Group Ltd. | CZW | Class II | |
| K100143 | Pilot Diode Laser, Model 002-00139 | Cao Group, Inc. | GEX | Class II | |
| K100098 | Plasmalipo/plasma D30 Lser Surgical Device | Jm System Co., Ltd. | GEX | Class II | |
| K093553 | Posturetek | Perseus Althetics,Llc | LZW | Unclassified | |
| K093459 | Elia Gliadin Dp Iga Immunoassay and Elia Gliadin Dp Igg Immunoassay, Models 14-5538-01, 14-5539-01 | Phadia AB | MST | Class II | |
| K093362 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | FKT | Class II | |
| K093145 | Spectra Series Breast Pump | Uzinmedicare Co., Ltd. | HGX | Class II | |
| K092991 | O.s.c.a.r. (Operating System for Control and Record Keeping) | Environmental Tectonics Corp. | CBF | Class II | |
| K092875 | Echo Td-3227 Dual Blood Pressure/blood Glucose Meter | Taidoc Technology Corporation | NBW | Class II | |
| K102113 | Ge Venue 40 Compact Diagnostic Ultrasound | GE Medical Systems China Co., Ltd. | IYN | Class II | |
| K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Intl., Inc. | GEI | Class II | |
| K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System | FUJIFILM SonoSite,Inc. | ITX | Class II | |
| K101051 | Avs a-Lat Peek Spacers, Models 48750Xxx, 48751Xxx, 48752Xxx, 48753Xxx | Howmedica Osteonics Corp | MAX | Class II | |
| K100978 | Powder Free Non-Sterile Vinyl Examination Glove | Jiangsu Sunshine Plastic Products, Co., Ltd. | LYZ | Class I | |
| K100977 | Pre-Powdered Vinyl Patient Examination Glove, Non-Sterile | Jiangsu Sunshine Plastic Products, Co., Ltd. | LYZ | Class I | |
| K100970 | Stainless Steel Spinal System | Theken Companies LLC | NKB | Class II | |
| K100551 | Orlocate System Model Orl 100 | Haldor Advanced Technologies, Ltd. | LWH | Class I | |
| K100389 | Hhc Push-Button Replacement Turbine for Midwest Tradition Handpiece Model Mw Turbine Replacement | Handpiece Headquarters | EFB | Class I | |
| K093828 | Kyph X Hv-R Bone Cement | Medtronic, Inc. | NDN | Class II | |
| K091692 | Aesculap Peek Craniofix | Aesculap Inc | GXR | Class II | |
| K102128 | Vitablocs | Vita Zahnfabrik H.Rauter GmbH & Co. | EIH | Class II | |
| K102025 | Combat Ready Clamp | Safeguard US Operating LLC | DXC | Class II | |
| K101937 | Hybrid Trocar System | Aesculap Inc | GCJ | Class II | |
| K101677 | Hospira Infusion Blood Sets | Abbott Medical | FPA | Class II | |
| K101660 | ECG Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 | Kepler Medtec | DSA | Class II | |
| K101658 | Waterlase Md Turbo Plus Model 7200Xxx | Biolase MG LLC | GEX | Class II | |
| K101479 | Wingman Extendable Tip Support Catheter | ReFlow Medical, Inc | DQY | Class II | |
| K101052 | Omni III Patient Monitor | Infinium Medical, Inc | MWI | Class II | |
| K100865 | Ava Navigator Peek Spacers, Model 48392Xxx, 48393Xxx | Howmedica Osteonics Corp | MAX | Class II | |
| K100156 | Collagen Dental Membrane V | Collagen Matrix, Inc | NPL | Class II | |
| K093692 | Quantum/ Streamline Spinal System Model 02-Series and 10-Series | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | Class II | |
| K093304 | Protektor 32 | Bio-Logic Systems Corp. | GWF | Class II | |
| K091310 | Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 | Dfine, Inc. | GEI | Class II | |
| K101960 | Sonotrax Series Ultrasonic Pocket Doppler | Edan Instruments, Inc. | HEP | Class II | |
| K101751 | Varian Unique Single Energy Linear Accelerator | Varian Medical Systems, Inc. | IYE | Class II | |
| K101691 | Lifelines Photic Stimulator | Lifelines Ltd. | GWE | Class II | |
| K101666 | Syngo. Plaza Va20a | Siemens AG Medical Solutions | LLZ | Class II | |
| K101372 | Duocool Pain Management Probe, Model Osp-17-180-20 | Baylis Medical Co., Inc. | GXI | Class II | |
| K100973 | Evolution Unicondylar Knee System | Wrightmedicaltechnologyinc | HRY | Class II | |
| K100743 | Atlas Spine Pivoting System | Atlas Spine, Inc. | MAX | Class II | |
| K100693 | Aquanova Ag Super Absorbant Dressing, Aquanova Ag Antimicrobial Dressing | Medtrade Products Ltd. | FRO | Unclassified |