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 |
|---|---|---|---|---|---|
| K010879 | Uniglove Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | N.S. Uni-Gloves Sdn. Bhd. | LYY | Class I | |
| K010816 | Dento-Prep Particle Microblaster | Ronvig A/S | KOJ | Class II | |
| K010794 | Bridge III Receiver | Meridian Medical Technologies, Ltd. | DXH | Class II | |
| K010696 | Beckman Coulter Dnase B Calibrator | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K010458 | The Maestro System | BioHorizons Implant Systems Inc | DZE | Class II | |
| K010291 | Iti Dental Implant System | Straumann USA, LLC | DZE | Class II | |
| K003754 | Immunetics C6 Lyme Elisa Kit | Immunetics, Inc. | LSR | Class II | |
| K003400 | Crp Hs Test System | Roche Diagnostics GmbH | DCN | Class II | |
| K011077 | Andersen Intestinal Tube, Miller-Abbott Type (an 22) | Andersen Products, Inc. | KNT | Class II | |
| K011065 | Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (Sono) | Richard Wolf Medical Instruments Corp. | FFK | Class II | |
| K010633 | Rigidfix Soft Tissue Acl Crosspin System | Mitek Products | HWC | Class II | |
| K010420 | Rusch Mmg/o'neil Catheter | Rusch, Inc. | FCM | Class II | |
| K010380 | Mp3hd Big Boy, Power Wheelchair | Merits Health Products, Inc. | ITI | Class II | |
| K011271 | Powder-Free Latex Examination Glove, Blue Colored | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K011267 | Exhale RF Probe | Broncus Technologies, Inc. | EOQ | Class II | |
| K011204 | Neurofax, Models EEG-1100A, EEG-9100A | Nihon Kohden America Inc | OLV | Class II | |
| K011142 | Aquarius Workstation | Terarecon, Inc. | LLZ | Class II | |
| K011120 | Glucopro Infusion Set, Model Gpisxxxxxxxx Series | Nipro Diabetes Systems, Inc. | FPA | Class II | |
| K011097 | Quickvue Dipstick Strep a | Ortho-Clinical Diagnostics, Inc. | GTY | Class I | |
| K011039 | Omnilink .018 Biliary Stent System | Boston Scientific Corporation | FGE | Class II | |
| K010825 | Medline Steriset Sterilization Container | Medline | FRG | Class II | |
| K010700 | Randox Myoglobin | Randox Laboratories, Limited | DDR | Class II | |
| K010691 | Blood Oxygenation Level Dependent (Bold) Option | Philips North America LLC | LNH | Class II | |
| K010595 | Dj Orthopedics Interference Screw | DJ Orthopedics, LLC | HWC | Class II | |
| K010542 | Snn System Including the Tomoguide Option | Surgical Navigation Specialists, Inc. | HAW | Class II | |
| K010479 | Multitak Conical Tip Bone Soft Tissue Suture Anchor | Bonutti Research, Inc. | HTY | Class II | |
| K010472 | Patient Dose Verification System, Model Tn-Rd-50 | Thomson & Nielsen Electronics, Ltd. | IYE | Class II | |
| K010369 | Claris Plate System | Ortho Tec, LLC | MNH | Class II | |
| K003735 | Blackstone Spinal Fixation System, Second-Generation Cross-Connector | Blackstone Medical, Inc. | MNI | Class II | |
| K003043 | Surgical Titanium Mesh System | Depuyacromed | MQP | Class II | |
| K002824 | Macs Modular Anterior Construct System | Aesculap Inc | KWQ | Class II | |
| K001120 | Envoy Patient Monitor | Mennen Medical, Inc. | DSI | Class II | |
| K010813 | Simplict | Neorad AS | JAK | Class II | |
| K010677 | Xps 3000 System | Medtronic Xomed, Inc. | HRX | Class II | |
| K010666 | Xps 3000 System with Reciprocating Adapter and Suction Cannulae | Medtronic Xomed, Inc. | QPB | Class II | |
| K010605 | Atlast Data Management Software (Dms) | Amira Medical, Inc. | CGA | Class II | |
| K010582 | Acon Strep a Rapid Test Strip | Acon Laboratories, Inc. | GTY | Class I | |
| K010520 | Gem Premier 3000- Addition of Glucose and Lactate as New Parameters | Instrumentation Laboratory Co. | CGA | Class II | |
| K010475 | D/c Core Material | Parkell, Inc. | EBF | Class II | |
| K010361 | Medtronic Ps Medical Invisx Cranial Fixation System, Model 60100-60900 | Medtronic PS Medical | GXR | Class II | |
| K003405 | Endoscopic Monopolar Forceps-Scissors, Emf-2000 to 2999,Endoscopics Monopolarfoeps-Graspers, Emf-3000 to 3999, Endoscopo | Highland / Marietta, Inc. | KNF | Class II | |
| K003403 | Endoscopic Monopolareectrode, Model Eme- 1000 to 1999 | Highland / Marietta, Inc. | JOS | Class II | |
| K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability | Advanced Technology Laboratories, Inc. | IYN | Class II | |
| K011178 | Wilson-Cook Thru-the-Scope Mechanical Lithotriptor | Wilson-Cook Medical Inc. | LQC | Class II | |
| K011136 | Apex Fixation Pins | Howmedica Osteonics Corp | JDW | Class II | |
| K011098 | Reveal Plus Insertable Loop Recorder System Model 9526 Implantable Recorder and Model 6191 Patient Activator | Medtronic, Inc. | MXC | Class II | |
| K011067 | Modification to Tsrh Spinal System | Medtronic Sofamor Danek | MNI | Class II | |
| K011050 | Microstream Oral Nasal Cannula Filterline | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K010449 | IVD (in Vivo Dosimeter), Model 1131 | Sun Nuclear Corporation | IYE | Class II | |
| K003943 | Microgas 7650 Transcutaneous Monitor | Linde Medical Sensors AG | KLK | Class II |