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 |
|---|---|---|---|---|---|
| K072613 | Directview, Lightguide, Model(s) 10Rll-320 Laparoscope, 10Dlg-320 Disposable Light Guide for Above | Micro Invasive Technology, Inc. | GCJ | Class II | |
| K072064 | Gravilax Traction System | Therapeutic Clinical Technologies, Inc. | ITH | Class II | |
| K080961 | Nm Application Suite | Philips North America LLC | LLZ | Class II | |
| K080945 | Fcr Go Portable Digital X-Ray System | FUJIFILM Healthcare Americas Corporation | IZL | Class II | |
| K080805 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | KWP | Class II | |
| K080757 | Amplatzer Torqvue Low Profile Delivery System | Abbott Medical | DQY | Class II | |
| K080311 | Modified Temprx Esthetic Provisional System | Dentsply Interntional | EBG | Class II | |
| K073269 | Hc1000p Sleep Diagnosis Software System | Hypnocore, Ltd. | MNR | Class II | |
| K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | NBW | Class II | |
| K072905 | 3Test Supreme Glucose Monitoring System | Neuero Engineering, Inc. | NBW | Class II | |
| K072714 | Tina-Quant Hemoglobin A1c Gen.2 Test System | Roche Diagnostics GmbH | LCP | Class II | |
| K072682 | 50W Ceralas D 1950Nm Diode Laser | Biolitec, Inc. | GEX | Class II | |
| K072548 | Creatine Kinase Liquid Reagent, Model C519-440 | Teco Diagnostics | CGS | Class II | |
| K071447 | Varios 75 | Nakanishi Inc. | ELC | Class II | |
| K063810 | Yulex Latex Powder-Free Exam Gloves | Yulex Corporation | OIG | Class I | |
| K080863 | Traxcess 0.014 Hydrophilic Guidewire | Terumo Cardiovascular Systems Corporation | DQX | Class II | |
| K080787 | Biomove 5000 System | Curatronic, Ltd. | IPF | Class II | |
| K080774 | Capiox Sp Pump (with or without X-Coating) | Terumo Cardiovascular Systems Corporation | KFM | Class II | |
| K080704 | Low Fluid Alarm | Em-Tec GmbH | FLN | Class II | |
| K080608 | Digital Lightbox | Brainlab, Inc. | LLZ | Class II | |
| K080525 | Cook Odyssey Holmium Laser System, Model 30W | Cook Incorporated | GEX | Class II | |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement Prostheses | Grace Medical, Inc. | ETB | Class II | |
| K073690 | Interlace Medical Hysteroscopic Morcellation System | Interlace Medical, Inc. | HIH | Class II | |
| K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905 | Vascular Solutions LLC | DQO | Class II | |
| K072729 | Sierra | Seaspine, Inc. | KWP | Class II | |
| K071261 | Isobar Semi-Rigid Dual Dampener | Scient'X | NQP | Class II | |
| K080929 | Oncentra Gyn | Nucletron BV | MUJ | Class II | |
| K080736 | Actifuse Shape Bone Graft Substitute | Apatech Ltd. | MQV | Class II | |
| K080691 | C-Qur Edge Mesh V-Patch | Atrium Medical Corporation | FTL | Class II | |
| K080688 | C-Qur Lite Mesh V-Patch | Atrium Medical Corporation | FTL | Class II | |
| K080567 | Palomar Aspire Laser Platform | Palomar Medical Products, Inc. | GEX | Class II | |
| K080553 | Digital Radiography System, Model Qxr-16 | Vieworks Co., Ltd. | KPR | Class II | |
| K080526 | Sierra System | Seaspine, Inc. | KWP | Class II | |
| K080270 | Manual Rigid Mobility Wheelchair | Freedom Designs Inc | IOR | Class I | |
| K080082 | Oxlife Independence Oxygen Concentrators | Oxlife, Inc. | CAW | Class II | |
| K080058 | Turbo Prime Ibd System | Spineselect, LLC | MAX | Class II | |
| K073449 | Surgicase | Materialise N.V. | LLZ | Class II | |
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures | Medtronic, Inc. | KDD | Class I | |
| K071591 | Ramp Influenza A/b Assay | Response Biomedical Corp. | PSZ | Class II | |
| K072614 | Matang Black, Powder Free and Polymer Coated Latex Examination Glove | Matang Mfg. Sdn. Bhd. | LYY | Class I | |
| K070570 | Dio Implant System | Dio Department Dsi, Inc. | DZE | Class II | |
| K062691 | Comporus | Takiron Co., Ltd. | MQV | Class II | |
| K080373 | Tacahe Pc1350 Power Wheelchair | Dalton Medical Corp. | ITI | Class II | |
| K080308 | Bio-Scaffold Bioscaff Alvelac Resobable Scaffold | Bioscaffold International Pte, Ltd. | LYC | Class II | |
| K080039 | Passive Waste Gas Scavenger, Model 14600 | G. Dundas Co. | CBN | Class II | |
| K073497 | Hdl Cholesterol Reagent, Model 10211 | Medica Corp. | LBS | Class I | |
| K072598 | Irsg I-Mover for Beds | International Retail Services Group, LLC | FPO | Class II | |
| K072201 | Compumedics Somte Psg Recording System | Compumedics Limited | MNR | Class II | |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112 | Wallac Oy | CGZ | Class II | |
| K080927 | Brightview Vct Imaging System | Philips North America LLC | KPS | Class II |