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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K150393 | Tetric Evoflow Bulk Fill | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K150034 | AMT Enteral Transition Adapters | Applied Medical Technology Inc | PIO | Class II | |
| K143520 | SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) | Crosstex | JOJ | Class II | |
| K142906 | APTUS Wrist 2.5 System | Medartis AG | HRS | Class II | |
| K142770 | Powered Wheelchair | AAT Alber Antriebstechnik GmbH | ITI | Class II | |
| K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | ODP | Class II | |
| K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System | Bionime Coporation | NBW | Class II | |
| K151301 | BD Veritor™ System Flu A+B Assay | Becton Dickinson & Co | PSZ | Class II | |
| K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | OCZ | Class II | |
| K150725 | Visaris Avanse | Visaris d.o.o. Belgrade | KPR | Class II | |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, LLC | OVD | Class II | |
| K150466 | ZX2 Laser System | Lzr7, Inc. | ILY | Class II | |
| K143466 | Hemogrip Patch | Remedium Technologies, Inc. | QSY | Unclassified | |
| K142327 | smARTrack Feeding Tube System | Art Healthcare, Ltd. | KNT | Class II | |
| K132058 | Vidas Ft4 | bioMerieux, Inc. | CEC | Class II | |
| K151082 | MicroCross Catheter | Roxwood Medical, Inc. | DQY | Class II | |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set | Immunalysis Corporation | LDJ | Class II | |
| K151060 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | IYO | Class II | |
| K151001 | MUSE System | Medigus, Ltd. | ODE | Class II | |
| K150761 | Ez3D-i/E3 | Ewoosoft Co., Ltd | LLZ | Class II | |
| K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring System | Abbott Medical | NBW | Class II | |
| K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | GZB | Class II | |
| K150332 | FreeStyle Lite Blood Glucose Monitoring System | Abbott Medical | NBW | Class II | |
| K150294 | DPZ Pedicular Fixation System | Osteomed Implantes, Ltda | MNI | Class II | |
| K150186 | Chariot Guiding Sheath | Boston Scientific Corporation | DYB | Class II | |
| K150140 | MCL 31 Dermablate | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K150109 | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology | Arrow International (A Subsidiary of Teleflex, Inc.) | FOZ | Class II | |
| K143715 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Better Plastic Co., Ltd. | LYZ | Class I | |
| K143380 | Phasix ST Mesh | C.R. Bard Inc | OWT | Class II | |
| K143002 | Metallic Locking Bone Plate and Screw System | Changzhou Dingjian Medical Appliance Co., Ltd. | HRS | Class II | |
| K142518 | HumaPen Luxura | Eli Lilly and Company, Pharmaceutical Delivery Systems | FMF | Class II | |
| K142503 | Imed-Z Fluid Status Monitor | Intersection Medical, Inc. | DSB | Class II | |
| K140021 | Ti-Oss | Chiyewon Co., Ltd. | NPM | Class II | |
| DEN130033 | Cognivue | Cerebral Assessment Systems, Inc. | PKQ | Class II | |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup | Assure Tech LLC | DIS | Class II | |
| K150976 | Collage | Anatomage, Inc. | LLZ | Class II | |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | KWP | Class II | |
| K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | JDQ | Class II | |
| K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | NKG | Class II | |
| K150472 | NxStage System One | NxStage Medical Inc | ODN | Class II | |
| K150443 | ToeTac Hammertoe Fixation System | Restore Surgical, LLC dba Instratek | HWC | Class II | |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | Remington Medical | BSP | Class II | |
| K150012 | CreoDent Solidex Customized Abutment | Creodent Prosthetics Ltd | NHA | Class II | |
| K143590 | Alevicyn SG Antipruritic Gel | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K143570 | Wirion | Gardia Medical | NTE | Class II | |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter | Natec Medical Ltd | LIT | Class II | |
| K142833 | INTRAGen | Jeisys Medical Inc. | OUH | Class II | |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II | Ortho-Clinical Diagnostics, Inc. | PDJ | Class II | |
| K142446 | Fixtemp Cement | Exacta Dental Direct, Inc. | EMA | Class II |