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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Ltd | OMP | Class II | |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | Innovative BioCeramix, Inc | KIF | Class II | |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | Biopoly, LLC | KWD | Class II | |
| K222895 | DynamicIQ | GE Medical Systems SCS | KPS | Class II | |
| K222237 | Cala kIQ | Cala Health, Inc. | QBC | Class II | |
| K222160 | GUS610 Blood pressure monitor | Globalcare Medical Technology Co., Ltd | DXN | Class II | |
| K222054 | Denti.AI Auto-Chart | Denti.ai Technology Inc. | LLZ | Class II | |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | |
| K221946 | LED Light Therapy Mask (model: MK66R-B) | Light Tree Ventures Europe B.V. | OHS | Class II | |
| K221716 | Cina | Avicenna.ai | QAS | Class II | |
| K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) | Edwards Lifesciences LLC | DQK | Class II | |
| K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health Inc. | POK | Class II | |
| K221608 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether | Anx Robotica Corp. | QKZ | Class II | |
| K221530 | ANNE Pediatric | Sibel, Inc. | DRG | Class II | |
| K221499 | Minimally Invasive Prostate Surgery Navigation System | Augment Intelligent Medical System (China) Co., Ltd. | LLZ | Class II | |
| K221471 | E3 and Profile | Diagnosys LLC | GWE | Class II | |
| K221412 | ARIX Rib System | Jeil Medical Corporation | HRS | Class II | |
| K221250 | EasyOne Filter | NDD Medizintechnik AG | CAH | Class II | |
| K221123 | WISE Cortical Strip (WCS) | Wise S.r.l. | GYC | Class II | |
| K220663 | AccuCTP | ArteryFlow Technology Co., Ltd. | LLZ | Class II | |
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products Inc. | OXZ | Class II | |
| K212736 | Canady Flex RoboWrist | US Medical Innovations, LLC | GCJ | Class II | |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech, Ltd. | FRF | Class II | |
| K223257 | Miro3D Wound Matrix | Reprise Biomedical, Inc. | KGN | Unclassified | |
| K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | QIH | Class II | |
| K222980 | Pentax Medical Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd | ODC | Class II | |
| K222951 | Sm-V | Sedecal S.A. | IZL | Class II | |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts, Inc. | JDR | Class II | |
| K222420 | Disposable Blood Pressure Cuff | Wenzhou Xikang Medical Instruments Co., Ltd. | DXQ | Class II | |
| K222390 | Flex-Thread™ Ulna Intramedullary Nail System | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HSB | Class II | |
| K222372 | Kowa SL-19 | Kowa Company, Ltd. | HJO | Class II | |
| K222246 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co.,Ltd | QRL | Class II | |
| K221811 | Vista BC Sealer | Inter-Med, Inc. | KIF | Class II | |
| K221268 | SR-1 Skin Treatment System | Avava, Inc. | ONG | Class II | |
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | FPA | Class II | |
| K221075 | Infusion Sets for Single Use | Sichuan Prius Biotechnology Co., Ltd. | FPA | Class II | |
| K221069 | Infusion Sets for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | FPA | Class II | |
| K220846 | Core-Snare | Incore Co., Ltd. | FDI | Class II | |
| K212936 | Vision Monitor- MonCvONE | Metrovision | GWE | Class II | |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd | EBW | Class I | |
| K221282 | Empatica Health Monitoring Platform | EMPATICA S.r.l. | DQA | Class II | |
| K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | SRI Trang Gloves (Thailand) Public Company Limited. | LZA | Class I | |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Medrad, Inc. | NBW | Class II | |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | BZQ | Class II | |
| K223124 | Expd 86P, Expd 86Pg, Expd 129P, Expd 129Pg | DRTECH Corporation | MQB | Class II | |
| K223003 | Banded Face Mask | Hubei Medlink Healthcare Co., Ltd. | FXX | Class II | |
| K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies | OVE | Class II | |
| K222816 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. Ltd. | JWH | Class II | |
| K222701 | MANTA Laser | Squalus Med, Ltd. | GEX | Class II |