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 |
|---|---|---|---|---|---|
| K063622 | Finecube Dental CT | The Yoshida Dental Mfg. Co., Ltd. | OAS | Class II | |
| K063617 | Eusol-C | Al.chi.mi.a. SRL | LYX | Unclassified | |
| K063564 | Microscan Synergies Plus Gram-Positive Mic/combo Panels with Chloramphenicol (4-16 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K063522 | Powder Nitrile Examination Glove (White and Blue Color) | HL Rubber Industries Sdn Bhd | LZA | Class I | |
| K062961 | Microlux Transilluminator | Addent, Inc. | NTK | Class II | |
| K062901 | Hemocath II | Med-Conduit, Inc. | MSD | Class II | |
| K062894 | Instantcheck Rtd-ECG Monitor, Model Rmh4.0 | Dailycare Biomedical, Inc. | DPS | Class II | |
| K062753 | Forsure Disposable Syringe with Needle, Model 1Cc, 3C, 5Cc, 10Cc, 20Cc, 50Cc | Surgimed Corp. | FMF | Class II | |
| K062478 | Clavis | Medtronic, Inc. | BXN | Class II | |
| K061309 | Embryoassist | Medicult A/S | MQL | Class II | |
| K061131 | Dbx-H Hemostatic Demineralized Bone Matrix Putty | Orthocon, Inc. | MBP | Class II | |
| DEN060003 | Tephaflex Absorbable Suture | Tepha, Inc. | NWJ | Class II | |
| K070219 | Suniray II Digital Radiography System | Suni Medical Imaging, Inc. | MUH | Class II | |
| K070046 | Powdered Vinyl Patient Glove | Shijiazhuang Lianhe Shunda Plastic Products Co., L | LYZ | Class I | |
| K063831 | Basal Dorsal Plates | Newdeal SAS | HRS | Class II | |
| K063660 | OTC TENS for Low Back Pain Relief, Model Wl-2407 | Well-Life Healthcare Limited | NUH | Class II | |
| K063603 | Suturtek Surgical Steel Suture, Models Sc-S13, Sc-S14, Sc-S15, Sc-S16, Sc-S17 | Suturtek Incorporated | GAQ | Class II | |
| K062793 | Servo-I Ventilator System, Model 64 87 800 E407e; Nava Option | Maquet Critical Care AB | CBK | Class II | |
| K061982 | Plexur P | Osteotech Inc | MBP | Class II | |
| K060564 | Infiniti System | AutoGenomics, Inc. | NPQ | Class II | |
| K063856 | Ez-Fill Xpress Epoxy Root Canal Cement System | Essential Dental Systems, Inc. | KIF | Class II | |
| K063840 | Xper Information Management/physiomonitoring 5 System And/or Vascular 5, Patient Care Console and Central Station | Invivo Corporation | MWI | Class II | |
| K063167 | Emma Analyzer (Kpa) and (Mmhg); Emma Monitor (Kpa) and (Mmhg) | Phasein AB | CCK | Class II | |
| K062799 | Gluco Track Blood Glucose Monitoring System | Apex Biotechnology Corp. | CGA | Class II | |
| K062554 | Starclose Hex-Hub Dilator | Abbott Vascular | DRE | Class II | |
| K061516 | Staodyn Max Preset, Model 4470 | Compex Technologies, Inc. | GZJ | Class II | |
| DEN070009 | Mammaprint | Agendia Inc | NYI | Class II | |
| K070297 | Clearview Dental Handpiece Lubricator and Lubricant | Dental Air Solutions of Nc, Inc. | EFB | Class I | |
| K070069 | Zipprep Electrode | Aspect Medical Systems, Inc. | GXY | Class II | |
| K063800 | Candela Fluorescent Pulsed Light System | Candela Corporation | GEX | Class II | |
| K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | GEX | Class II | |
| K063521 | Nissin Pediatric Series Wheelchair | Nissin Medical, Inc. | INM | Class I | |
| K063368 | Nipro Biohole Needle | Nipro Medical Corporation | FIE | Class II | |
| K063135 | Sonic-Stim | Naimco, Inc. | IMG | Class II | |
| K062912 | Scient'x Spinal System | Scient'X | MNI | Class II | |
| K062893 | Kodea, Models Xj-2001Ac; Xj-2002As; Xj-2003A | Shanghai Kodea Economic and Trade Development, Ltd. | DXN | Class II | |
| K062646 | Ruike, Model 3411 | Shanghai Ruike Sports Goods Co., Ltd. | INI | Class II | |
| K062339 | Dermotherap Gun | Dermoequipos S.r.l. | KZH | Class II | |
| K062205 | Dbx Strip | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | MBP | Class II | |
| K062098 | Spectrum Monitor, Model 0998-00-1000-Xxxxx | Datascope Corp. | MHX | Class II | |
| K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | OMP | Class II | |
| K070078 | Stryker T4 Hytrel Toga | Stryker Corp. | FYA | Class II | |
| K070001 | Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, Tm5 Low Speed Handpiece and Tm20 Low Speed Handpiece | Mti Precision Products | EFB | Class I | |
| K063816 | Pca Alumina Femoral Heads | Stryker Orthopaedics | LZO | Class II | |
| K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 Sp-1A, 66120 Sp-1A, 69150 Sp-2A, 69120 L USA Sp-2A, 69180 Sp-2Ha | Tuttnauer Ltd. | FLE | Class II | |
| K063672 | Fibula Plate Prolock with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | HRS | Class II | |
| K063593 | Clearfil Majesty Flow | Kuraray America, Inc. | EBF | Class II | |
| K063515 | Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee | Biomet Manufacturing Corp | HRY | Class II | |
| K063511 | Ceramill Zi | Amann Girrbach America, Inc. | EIH | Class II | |
| K063418 | Acon Digital Thermometer Probe Covers | Acon Laboratories, Inc. | FLL | Class II |