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 |
|---|---|---|---|---|---|
| K000834 | Castellni Air Powered Handpieces Syringes: Three Steril, Multisteril Turbins: Cleanair, Cleanlight Micromotors: Implanto | Castellini S.p.A. | EFB | Class I | |
| K003611 | Pain Care Multi-Port Catheter, Model 2000L | Breg, Inc. | FRN | Class II | |
| K003532 | Hardy Disk, Cefpodoxine, 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K003523 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | Depuy Orthopaedics Inc. | KWA | Class III | |
| K003520 | Nexan System, Model Nx-300 | Nexan, Ltd. | MWJ | Class II | |
| K003283 | Simplicity with Wings Infusion Set, (Model Mmt-103) | Sterling Medivations, Inc. | FPA | Class II | |
| K003241 | Ecat Pet Scanner | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K003195 | Greertrack Skin Testing System, Model Gt-It, Gt-Ic | Greer Laboratories Inc | SCL | Class II | |
| K003144 | Model 205Ge-64: Pathway MRI Carotid Array Coil | Medical Advances, Inc. | MOS | Class II | |
| K003071 | Glitter Eyes (Tefilcon) Soft (Hydrophilic) Contact Lens for Daily Wear | Alcon Laboratories | LPL | Class II | |
| K003067 | Caleo | Drager Medizintechnik GmbH | FMZ | Class II | |
| K003056 | Ovarial Biopsy Set 324102-324108; Ovarial Biopsy Set 324200-324202; Ovarial Biopsy Needle 32218 | Labotect Labor-Technik Gottingen | MQE | Class II | |
| K003044 | Copeland Resurfacing Heads | Zimmer GmbH | HSD | Class II | |
| K003016 | Pro-Femur R | Wrightmedicaltechnologyinc | LWJ | Class II | |
| K002985 | Ics Medical Chartr Ep and Chartr Oae Systems | Ics Medical Corp. | GWJ | Class II | |
| K001254 | Orthomatrix, Inc. Cerclage System | Orthomatrix, Inc. | JDQ | Class II | |
| K001233 | Acti-Flex Fluid Delivery System or Acti-Flex F D S | R-Group Intl. | FPA | Class II | |
| K003660 | Leibinger Neuro Clip System | Stryker Corp. | JEY | Class II | |
| K003616 | Colleague (3Cx, 3, Cx) Volumetric Infusion Pump | Baxter Healthcare Corporation | FRN | Class II | |
| K003249 | Pst Electrosurgical Generator, Model 2150, Pst Bipolar Forceps, Model Ebf 1228 | Pst, Inc. | GEI | Class II | |
| K003201 | Stealthstation Treatment Guidance Platform | Medtronic Navigation, Inc | HAW | Class II | |
| K002970 | Subdural Evacuating Port System, Model 11-9901 | Medical Designs, LLC | JXG | Class II | |
| K002899 | Opus 20, Model 1St | Opusdent, Ltd. | GEX | Class II | |
| K002569 | Glucosource Insulin Syringes and Malgam Single-Use Insulin and Single Use Hypodermic Syringes | Malgam Ent., Inc. | FMF | Class II | |
| K002411 | Shenling Acupuncture Needles | Shenling Medical Device Co., Ltd. | MQX | Class II | |
| K994146 | Epf-Plus Cementless Press-Fit Acetabular Cup | Plus Orthopedics | LWJ | Class II | |
| K003143 | Millennium Blades, Model Mb101 | Millennium Biomedical, Inc. | HNO | Class I | |
| K003078 | Merit Drainage Depot | Merit Medical Systems, Inc. | EXF | Class II | |
| K002996 | Synergy Ha Coated Porous Femoral Stems | Smith & Nephew, Inc. | MEH | Class II | |
| K002960 | Trilogy Acetabular System Large Head Liner, Model 6353 | Zimmer GmbH | LPH | Class II | |
| K002616 | Electric Mobility Rascal and Chauffer Scooters | Electric Mobility | INI | Class II | |
| K002395 | Model 30 Classic Pneumatonometer | Xomed, Inc. | HKX | Class II | |
| K001956 | Trident All Poly Cup | Howmedica Osteonics Corp | JDI | Class II | |
| K001550 | Ebt Ultrafast CT Scanner System; C-100, C-150, C-150Lxp or C-150Xp Scanner Systems; Electron Beam Scanner System; Electr | Imatron, Inc. | LLZ | Class II | |
| K001160 | Versabond Bone Cement | Smith & Nephew, Inc. | LOD | Class II | |
| K000851 | Psychemedics Analysis of Morphine in Hair | Psychemedics Corp. | DJG | Class II | |
| K000249 | Schaefer Water Center Hemodialysis Water Purification System, Model Hwps-100 | Schaefer Water Centers | FIP | Class II | |
| K002927 | Snare,flexible | Odon Lifetechnology | FDI | Class II | |
| K991613 | Sw Ultrasound, Models 331, 311, 333 | Starbene | IMI | Class II | |
| K003674 | Nezhat-Dorsey Reusable Electrosurgical Attachments: J-Hook Tip, L-Hook Tip, Corbitt Spatula Tip, Needle Tip, Ball Tip | Davol Inc., Sub. C.R. Bard, Inc. | GEI | Class II | |
| K003490 | Opus Rod Fixation System | Howmedica Osteonics Corp | MNH | Class II | |
| K003183 | Thermage Thermacool II System | Solta Medical, Inc. | GEI | Class II | |
| K003169 | Vascular Closure Device | Std Mfg., Inc. | GDW | Class II | |
| K003005 | Tissuelink Bipolar Forceps | Medtronic Navigation, Inc | GEI | Class II | |
| K003002 | Sterilization Process Indicator Tapes Model Ci112 & Ci123 | Steritec Products, Inc. | JOJ | Class II | |
| K002969 | Xltek Evoked Potential Headbox, Model Ep-8 | Xltek | GWF | Class II | |
| K002951 | Magellan Ventilator | Oceanic Medical Products, Inc. | CBK | Class II | |
| K002868 | Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard Lubri-Sil I.c. 3-Way Foley Catheter | C.R. Bard Inc | EZL | Class II | |
| K002845 | Paflufocon C and E Daily Contact Lens | Paragon Vision Sciences, Inc. | HQD | Class II | |
| K002841 | Cool-Tec Electrodes | Seedling Enterprises., LLC | GEI | Class II |