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 |
|---|---|---|---|---|---|
| K041762 | Finishing Wire Supportrak | Boston Scientific Corporation | DQX | Class II | |
| K041689 | Polyurethane Blood Pressure Cuffs | D. E. Hokanson, Inc. | DXQ | Class II | |
| K041629 | Lysus Infusion System | Ekos Corp. | QEY | Class II | |
| K041504 | Hemamyst Surgical Applicator System, Model H-As01 | Haemacure Corp. | FMF | Class II | |
| K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | DSB | Class II | |
| K040637 | Powerheart AED G3 Pro | ZOLL Medical Corporation | MKJ | Class III | |
| K040358 | Xltek Protektor Stimulator, Models 10247 & 10248 | Excel Tech., Ltd. | GWF | Class II | |
| K032884 | Filter Wire Ez Embolic Protection System and Ez Bent Tip Retrieval Sheath | Boston Scientific Epi | NFA | Class II | |
| K041752 | Teh Lin Powered Wheelchair, Mdg-601 | Teh Lin Prosthetic & Orthopaedic, Inc. | ITI | Class II | |
| K041721 | Lvi Aesthetic Laser | Hoya Photonics, Inc. | GEX | Class II | |
| K041691 | Clip 'N'ject Reconstitution System (Clip 'N'ject | West Pharmaceutical Services, Inc. | LHI | Class II | |
| K041677 | Karma Scooter, Model Ks-747.2 | Karma Medical Products Ltd. | INI | Class II | |
| K041589 | Arthrex Fiberwire with Silk | Arthrex GmbH | GAT | Class II | |
| K041517 | Infusioncath | Id, LLC | QEY | Class II | |
| K041316 | Antimicrobial Alginate Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K041289 | Talus of Vilex (Tov) | Vilex, Inc. | HWC | Class II | |
| K041287 | Vilex Bone Plate System | Vilex, Inc. | HWC | Class II | |
| K040731 | Stryker Spine Vertebral Spacer | Howmedica Osteonics Corp | MQP | Class II | |
| K033587 | Silverseal | Noble Fiber Technologies, Inc. | FRO | Unclassified | |
| K033580 | Nexflex Total Hip System | Nexmed, Inc. | LPH | Class II | |
| K032596 | Sturdy Manual Resuscitator | Sturdy Industrial Co., Ltd. | BTM | Class II | |
| K030819 | Plasmajet System | Plasma Surgical Inc. | GEI | Class II | |
| K041915 | Hemo-Dop | Dwl Elektronische Systeme GmbH | IYN | Class II | |
| K041886 | Proviso | Scientific Pharmaceuticals, Inc. | EBG | Class II | |
| K041519 | Modification to: on-Board Imager Device | Varian Medical Systems, Inc. | IYE | Class II | |
| K041415 | Eva Tpn Container | B.Braun Medical, Inc. | KPE | Class II | |
| K041219 | Electro | Permobil, AB | ITI | Class II | |
| K040798 | Hes Ultrasonic Therapy Appliance | Hwang Sun Enterprise Co., Ltd. | IMI | Class II | |
| K040082 | Pore-Si Bone Graft Substitute | Apatech Ltd. | MQV | Class II | |
| K033399 | Geodesic EEG System Series 100 | Electrical Geodesics, Incorporated | GWQ | Class II | |
| K033178 | Ultrabio | Sonotech, Inc. | MUI | Class II | |
| K041996 | Nightform | Plastic Surgery Solutions, LLC | FRP | Class I | |
| K041970 | Biotop Hooksafe Safety Syringe, Models 0.5Cc/ml, 1Cc/ml, 3Cc/ml, 5Cc/ml and 10Cc/ml | Biotop Technology Co., Ltd. | MEG | Class II | |
| K041806 | Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop | DePuy Mitek, Inc. | GAM | Class II | |
| K041796 | Precise Rx Nitinol Stent Transhepatic Biliary System | Cordis US Corp. | FGE | Class II | |
| K041776 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K041710 | Versawave Dental Er:yag Laser System | Hoya Conbio, Inc. | GEX | Class II | |
| K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K041384 | Bd Phoenix Automated Microbiology System - Ceftazidime - Gram Negative | Becton Dickinson & Co | LON | Class II | |
| K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | OLU | Class II | |
| K040343 | Temp F | Novocol, Inc. | EMA | Class II | |
| K033730 | Pmt Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 Series | PMT Corp. | GZL | Class II | |
| K033685 | Northrup Universal Annuloplasty System, Model 1000 | Medical Cv, Inc. | KRH | Class II | |
| K041485 | Marpac Messenger Model #501 | Marpac, Inc. | JOH | Class II | |
| K041378 | Bio 60 | Kodent, Inc. | EJT | Class II | |
| K041357 | Varelisa Gliadin Igg Antibodies | Sweden Diagnostics (Germany) GmbH | MST | Class II | |
| K041173 | Celikey Igg Itg Igg Antibodies, Model 17996 | Sweden Diagnostics (Germany) GmbH | MVM | Class II | |
| K041168 | Allomatrix Putty | Wrightmedicaltechnologyinc | MQV | Class II | |
| K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | KCT | Class II | |
| K041949 | Allura Xper Fd10 | Philips North America LLC | IZI | Class II |