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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K250877 | TMINI Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd | ODC | Class II | |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | CAF | Class II | |
| K250566 | EsCem RMGI | Spident Co., Ltd. | EMA | Class II | |
| K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | SDJ | Class II | |
| K250037 | Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) | HSN | Class II | |
| K243978 | LED Facial Mask | Shenzhen Sunsred Technology CO.,Ltd. | OHS | Class II | |
| K243589 | PAL Sterilization Case | MicroAire Surgical Instruments, LLC | KCT | Class II | |
| K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | JAK | Class II | |
| K243168 | Alinity i Rubella IgG | Abbott Medical | LFX | Class II | |
| K243120 | HybridAPC probe | ERBE Elektromedizin GmbH | GEI | Class II | |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Becton Dickinson & Co | PHC | Class II | |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | ClaroNav Inc. | PGW | Class II | |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | FLL | Class II | |
| K242985 | CollOvine™ Wound Dressing | Ovigenex LLC | KGN | Unclassified | |
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics Inc. | MSW | Class II | |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa | JXG | Class II | |
| K242964 | Celsi Warmer | Hadleigh Health Technologies | DWJ | Class II | |
| K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | PDJ | Class II | |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific Oy | JWY | Class II | |
| K251235 | Electrosurgical Pads | Baisheng Medical Co.,Ltd. | GEI | Class II | |
| K250515 | EpiMonitor | EMPATICA S.r.l. | POS | Class II | |
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.p.A. | OAT | Class II | |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International Inc | DJG | Class II | |
| K251530 | CONMED Argo Knotless® Anchor | ConMed Corporation | MBI | Class II | |
| K251296 | The Acumed Wrist Fixation System | Acumed LLC | HRS | Class II | |
| K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port | Bard Access Systems, Inc. | LJT | Class II | |
| K250908 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | NKB | Class II | |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips North America LLC | IYN | Class II | |
| K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems Ltd | DZE | Class II | |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | OVD | Class II | |
| K250492 | FlexiGo 3D Delivery Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | FXX | Class II | |
| K243672 | CardIQ Suite | GE Medical Systems SCS | JAK | Class II | |
| K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay LLC | ITH | Class II | |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote S.p.A. | IYN | Class II | |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | O&M Halyard, Inc. | LZA | Class I | |
| K243102 | Mobility Scooter (JT10) | Jiangxi Jiangte Electric Vehicle Co., Ltd. | INI | Class II | |
| K243039 | Ureteral Stents (AF-D series) | Alton Shanghai Medical Instruments Co Ltd | FAD | Class II | |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | HQF | Class II | |
| K242933 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | LNS | Class II | |
| K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | PIF | Class II | |
| K242894 | SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) | Shanghai Saints Sages Surgical Co., Ltd. | LFL | Unclassified | |
| K242224 | Happy Health Home Sleep Test | Happy Health | MNR | Class II | |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OAP | Class II | |
| K250997 | Integrity™ Implant | Anika Therapeutics, Inc. | OWX | Class II | |
| K250665 | Skr 3000 | Konica Minolta, Inc. | MQB | Class II | |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab, Inc. | MUJ | Class II |