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 |
|---|---|---|---|---|---|
| K092598 | Zoll E Series with Spco/spmet Option | ZOLL Medical Corporation | MKJ | Class III | |
| K093434 | Vertex Reconstruction System and Vertex Select Reconstruction System | Medtronic Sofamor Danek | NKB | Class II | |
| K093375 | Ks-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50Ug or Less) | Koon Seng Sdn Bhd | LYY | Class I | |
| K093313 | Synergy | Topcon Healthcare, Inc. | NFJ | Class II | |
| K093247 | Medsynapse Pacs Software | Medsynaptic Private Ltd. | LLZ | Class II | |
| K092958 | Avita Scaneo Ir Thermometer, Models Ts2x & Ts3x Series | Avita Corporation | FLL | Class II | |
| K092829 | Insertease | Christcot Medical Company | OOW | Class I | |
| K092771 | Dyna Locking Im Nail | CG MedTech Co., Ltd. | HSB | Class II | |
| K092710 | Pentax Ed-3490Tk, Video Duodenoscope | PENTAX of America, Inc. | FDT | Class II | |
| K092639 | Innova Vision, Model S18751vn, Innova Trackvision, Model S18751vt, Innova Epvision, Model S18751ep | GE Medical Systems SCS | LLZ | Class II | |
| K092614 | X-Smart Easy | Dentsply Interntional | EKX | Class I | |
| K091934 | Ig4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to Ig4 Endobronchial), Model Ins-0300 | Veran Medical Technologies, Inc. | JAK | Class II | |
| K091578 | Lift Chair, Model T3 | Pride Mobility Products Corp | INO | Class II | |
| K091111 | Rtc Metered Dose Inhaler Adapters-Single Patient Use, Model Rtc 24-V, Rtc Mdi Adapter Kit-Single Patient Use, Model Rtc | Instrumentation Industries, Incorporated | CAF | Class II | |
| K090636 | Tso3 Ozone Sterilizer, Model 125L | Tso3, Inc. | FLF | Class II | |
| K090526 | Medical Image Processing Unit, Model Ezsensor | E-Woo Technology | MUH | Class II | |
| K093531 | Acuson Model X300 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | IYN | Class II | |
| K093456 | Jetstream G3 System | Pathway Medical Technologies, Inc. | MCW | Class II | |
| K093057 | Biomet Vision Footring System | Ebi, LLC | KTT | Class II | |
| K092903 | Bora Up 2080, Bora Up 2080 Op and Bora Up 2080 Mounting | Maquet GmbH and Co. KG | BTA | Class II | |
| K092634 | Obs Disposable Electrosurgical Pencils, Models: Obs-Db, Obs-Dr, Obs-Df | Jiangmen City Xinhui Baisheng Medical Equipment Co | GEI | Class II | |
| K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd) | CAPTIVA SPINE, Inc. | MAX | Class II | |
| K090405 | Lipidpro System | Infopia Co, Ltd. | NBW | Class II | |
| K073214 | Duowedge Synthetic Bone Substitute | Kasios | MQV | Class II | |
| K093453 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | EAP | Class II | |
| K093277 | Powder-Free Vinyl Patient Examination Gloves | Tangshan Green Healthcare Co., Ltd. | LYZ | Class I | |
| K093272 | Powder-Free Vinyl Patient Examination Gloves | Tangshan Huamei Healthcare Co., Ltd. | LYZ | Class I | |
| K093146 | Ig4 Image Guided System, Model: Sys-0200 | Veran Medical Technologies, Inc. | JAK | Class II | |
| K092871 | Trilogy Mx | Varian Medical Systems, Inc. | IYE | Class II | |
| K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50Rf | Virtual Imaging, Inc. | OWB | Class II | |
| K092341 | Low Profile Abutments - Internal and External Connection | ZimVie US Corp LLC | NHA | Class II | |
| K092090 | Erbelift Hand Pump and Flexible Probe | Byrne Medical, Inc. | FBK | Class II | |
| K091248 | Maxems, Models 1000 and 2000 | Bio Protech, Inc. | IPF | Class II | |
| K093387 | Fully Automatic Electronic Blood Pressure Monitor Model Kd-5961, Kd-5962, Kd-5902 | Andon Health Co., Ltd | DXN | Class II | |
| K093359 | 1103 Digital Blood Pressure Monitor, Model Ld 1103, 1133 Digital Blood Pressure Monitor, Model Ld 1133 | Shanghai Little Doctor Co. Limited | DXN | Class II | |
| K093134 | Cerner Careaware Ibus | Cerner Corporation | DRG | Class II | |
| K092959 | Avita Radar Thermo Ir Thermometer, Model Nt 152 | Avita Corporation | FLL | Class II | |
| K092160 | Powderfree Nitrile (Dark Blue) Examination Gloves | Comfort Rubber Gloves Ind. Sdn. Bhd. | LZA | Class I | |
| K091824 | Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model In2507 | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K093564 | Sved Wound Treatment System | Innovative Therapies, Inc. | OMP | Class II | |
| K093521 | Gdxpro | Carl Zeiss Meditec Inc | MYC | Class II | |
| K093348 | 3.0T 16 Channel Head Neck Spine Coil | GE Healthcare Coils (USA Instruments, Inc.) | MOS | Class II | |
| K092732 | Propencil Esu Pencil | Bio Protech, Inc. | GEI | Class II | |
| K092693 | Viramed Biotech Ag Borrelia B31 Igg Virastripe, Model V-Bbsgus | Viramed Biotech AG | LSR | Class II | |
| K092567 | Modification to Unigraft | Unicare Biomedical, Inc. | LYC | Class II | |
| K092473 | Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K092230 | Mona - Orthopedic MRI System, Model Tms-200Orth-01 | Time Medical Limited | LNH | Class II | |
| K092191 | Exilis, Model 5000 | BTL Industries, Inc | GEI | Class II | |
| K090796 | Multi-Bite Hot Biopsy Forceps | Endo-Therapeutics, Inc. | KGE | Class II | |
| K090326 | Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems | Clarity Medical Systems | HKI | Class II |