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 |
|---|---|---|---|---|---|
| K011459 | Wujin #3 Femoral Bone Plate | Biopro, Inc. | HRS | Class II | |
| K011423 | Inpulse Dental Laser | Incisive, LLC | GEX | Class II | |
| K003281 | Lactosorb Rapidflap | Zimmer GmbH | JEY | Class II | |
| K993182 | Dispoprophy | Kis Products | KOJ | Class II | |
| K993124 | Dispodrill | Kis Products | KOJ | Class II | |
| K984380 | Dispo Etch | Kis Products | KOJ | Class II | |
| K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25 | Gebauer Co | LFD | Unclassified | |
| K012282 | Sterile Powder Free Synthetic Vinyl Patient Exam Glove | Cypress Medical Products LLC | LYZ | Class I | |
| K011751 | Travel Ease Electric Scooter, Model Pioneer 3 | Merits Health Products, Inc. | INI | Class II | |
| K011706 | Flexicast Prime | American Dent-All, Inc. | EJH | Class II | |
| K011666 | Chillit | Heatshield, Inc. | EAT | Class II | |
| K011416 | Muscle Imaging System (Mis) | Millennium Magnetic Imaging, Inc. | LNH | Class II | |
| K010534 | Cross-Checks Dual, Model Ci 125 | Steritec Products, Inc. | JOJ | Class II | |
| K002832 | Conductive Gel for Ultrasound | Skylark Device & Systems Co., Ltd. | GYB | Class II | |
| K002790 | Add-on Condyle | Biomet Microfixation | NEI | Class II | |
| K012370 | Solara Jr. Manual Wheelchair | Invacare GmbH | IOR | Class I | |
| K012257 | Emit II Plus Monoclonal Amphetamine/methamphetamine Assay Model Osr9c229 | Syva Co. | DKZ | Class II | |
| K012200 | 1.5T Infinity Twinspeed Mr System | GE Healthcare | LNH | Class II | |
| K012123 | Nidoil | Nidacon International AB | MQL | Class II | |
| K012068 | Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S | Abbott Medical | MQE | Class II | |
| K011971 | Navigus Trajectory Guide Biopsy Kit, Models Bk-7000 and 8000 | Image-Guided Neurologics, Inc. | HAW | Class II | |
| K011917 | Advanced Hip Assessment Software | GE Lunar Corp. | KGI | Class II | |
| K011768 | Thermo-Therapy, Models Tt-101, Tt-201, and Tt-202 | Thermo-Electric Co. | LSB | Class II | |
| K011753 | Travel Ease Electric Scooter, Model Pioneer 4 | Merits Health Products, Inc. | INI | Class II | |
| K011748 | First Fill R.c.s. | Jeneric/Pentron, Inc. | KIF | Class II | |
| K011707 | Travel Ease Electric Scooter Model # Pioneer 2 | Merits Medical Industries Co., Ltd. | INI | Class II | |
| K011705 | Supremcast | American Dent-All, Inc. | EJH | Class II | |
| K011687 | Mp-3C Power Base Chair, Model Mp3c | Merits Health Products, Inc. | ITI | Class II | |
| K011447 | In Space 3D | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K011443 | Threaded Cement Restrictor (Cr) Titanium | Medtronic Sofamor Danek USA Inc | JDK | Class II | |
| K011397 | Persyst Reveal | Persyst Development LLC | OMB | Class II | |
| K011386 | Ebi Osteostim Granules-Resorbable Bone Graft Substitute | Ebi, LLC | MQV | Class II | |
| K011102 | Anterior Cruciate Ligament (Acl) Instrument System | Aesculap Inc | HWC | Class II | |
| K011031 | Vysis Urovysion Bladder Cancer Recurrence Kit | Vysis | MMW | Class II | |
| K010530 | Geo Structure | Interpore Cross Intl. | MQP | Class II | |
| K010345 | Ksea Manhes Take-Apart Bipolar Coagulating Forceps | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K010295 | Microstim 100I TENS Device | Microstim, Inc. | GZJ | Class II | |
| K012085 | Somno Star & Series Sleep System | Sensor Medics Corp. | OLV | Class II | |
| K011951 | Ez Syringe | Owen Mumford Limited | FMF | Class II | |
| K011535 | Cadence Precision Injector, Model 103-0304 | Medtronic, Inc. | MJN | Class II | |
| K011458 | Synthes Straight Wrist Fusion Plate, 170Mm | Synthes (USA) Products LLC | KTW | Class II | |
| K011382 | Xtrac Excimer Laser System, Model Al 7000 | Photo Medex, Inc. | GEX | Class II | |
| K011368 | Dry Ac Acid Concentrate Mix for Bicarbonate Hemodialysis | Gambro Renal Products | KPO | Class II | |
| K010413 | Minolta Pulsox-3Si, Pulsox-3Ia, Pulsox-3Li | Konica Minolta Sensing, Inc. | DQA | Class II | |
| K012299 | Modification to: Straight Post and Core II for the Basic Dental Implant System | Basic Dental Implant Systems, Inc. | DZE | Class II | |
| K012281 | Trs-2000 Power Tilt/power Recline System | Accelerated Rehab Designs, Inc. | ITI | Class II | |
| K012255 | Medtronic Sofamor Danek Cement Restrictor | Medtronic Sofamor Danek | JDK | Class II | |
| K012217 | M5t Instant Fever Thermometer | Medisim Ltd. | FLL | Class II | |
| K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare GmbH | IOR | Class I | |
| K012166 | Nitrile Powder-Free Medical Examination Glove (Brown) | Best Manufacturing Company | LZA | Class I |