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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K172359 | UroLift System (UL500) | Neotract Inc | PEW | Class II | |
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | DRQ | Class II | |
| K172194 | Connector System | Orthofix SRL | NKG | Class II | |
| K172182 | QUANTIEN Measurement System | St. Jude Medical (Now Part of the Abbott Medical) | DQK | Class II | |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | NKG | Class II | |
| K171900 | Acclarix AX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs | Better Care Plastic Technology Co., Ltd. | KGO | Class I | |
| K171845 | EMBA Hourglass Peripheral Embolization Device | Emba Medical Limited | KRD | Class II | |
| K171738 | Supria True64 | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K171660 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | |
| K171407 | ExsoMed ArcPhix and ExsoMed ArrowPhix | Exsomed Holding Company, LLC | HWC | Class II | |
| K171406 | Optum TeleHealth Application | United Health Group, Inc. | DRG | Class II | |
| K171261 | ScannerSide DoseCheck | Right Dose, Inc. | JAK | Class II | |
| K171227 | StarWalker | Fotona d.o.o. | GEX | Class II | |
| K171183 | OmniTom | Samsung HME America, Inc. | JAK | Class II | |
| K171143 | Relievant Medsystems RF Generator | Relievant Medsystems | GXD | Class II | |
| K170825 | SnoreRx | Apnea Sciences Corporation | LRK | Class II | |
| K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | OWB | Class II | |
| K170782 | Medline UNITE® Snap-Off Screws | MEDLINE INDUSTRIES, LP - Northfield | HWC | Class II | |
| K170667 | QEVO System with KINEVO 900 | Carl Zeiss Meditec Inc | GWG | Class II | |
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip | Coeur, Inc. | DXT | Class II | |
| K170149 | 3DMetal Tibial Cones | Medacta International SA | JWH | Class II | |
| K170003 | Zip 4 Skin Closure Device | Zipline Medical, Inc. | PYO | Class I | |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories, Inc. | DHA | Class II | |
| K163359 | ARK Methotrexate Assay | Ark Diagnostics Inc | LAO | Unclassified | |
| K161679 | s LDL-EX SEIKEN | Denka Seiken Co., Ltd. | PYP | Class I | |
| DEN160025 | ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit | ID-Fish Technology, Inc | PYN | Class II | |
| K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DTQ | Class II | |
| K172204 | BD Intima II PLUS Closed IV Catheter System | Becton Dickinson & Co | FOZ | Class II | |
| K172165 | Q-Fix Suture Anchor | ArthroCare Corporation | MBI | Class II | |
| K171993 | Zimmon Needle Knife Papillotome | Wilson-Cook Medical Inc./Cook Endoscopy | KNS | Class II | |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical Ltd | KNS | Class II | |
| K171793 | Sequential Circulator SC-2004FC-OC | Bio Compression Systems, Inc. | JOW | Class II | |
| K171475 | DeRoyal Laprador Specimen Retrieval System | DeRoyal Industries, Inc. | GCJ | Class II | |
| K171156 | OMNI Anseris Hip Stem | Omni Life Science, Inc. | LZO | Class II | |
| K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories | GE Healthcare Finland Oy | CCK | Class II | |
| K170979 | ARIX Ankle Fibula Hook Plate System | Jeil Medical Corporation | HRS | Class II | |
| K170555 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical L.L.C. | PIF | Class II | |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | MEDLINE INDUSTRIES, LP - Northfield | EZN | Class II | |
| K170384 | Dentium NR Line CAD/CAM Abutments | Dentium Co., Ltd. | NHA | Class II | |
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | Ion Beam Applications S.A. | LHN | Class II | |
| K163339 | Spectralmd Deepview Wound Imaging System 2.0 | Spectralmd, Inc. | DPT | Class II | |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical | DWM | Class II | |
| K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | SCL | Class II | |
| K172426 | Clear Blue Digi LED Curing Light | Promident, LLC | EBZ | Class II | |
| K172175 | CapSure® PS System | Spine Wave Inc | NKB | Class II | |
| K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare GmbH | IYN | Class II | |
| K171950 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) | Visionary Optics, LLC | HQD | Class II | |
| K171651 | Excelsius Gps | Globus Medical, Inc. | OLO | Class II | |
| K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | HSN | Class II |