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 |
|---|---|---|---|---|---|
| K250776 | Lithoblast Single Use Holmium Laser Fibers | Dawell Medical, LLC | GEX | Class II | |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | FRO | Unclassified | |
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | MQV | Class II | |
| K251595 | COVID-19 Detect Rapid Self -Test | Inbios International, Inc. | QYT | Class II | |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd. | NFO | Class II | |
| K242227 | Geneo X Elite | Pollogen Ltd | PAY | Class II | |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | GEH | Class II | |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | ODP | Class II | |
| K252544 | TMINI Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | HWC | Class II | |
| K252209 | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) | Foshan Jindi Electric Appliance Co.,Ltd | OHT | Class II | |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | KGN | Unclassified | |
| K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical Inc. | SGE | Class II | |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US LLC | FRO | Unclassified | |
| K251835 | Yomi Robotic System | Neocis Inc. | PLV | Class II | |
| K251708 | EvoEndo Single-Use Endoscopy System | Evoendo, Inc. | FDS | Class II | |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | OWB | Class II | |
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | PROCEPT BioRobotics Corporation | PZP | Class II | |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corp. | KNS | Class II | |
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | GMQ | Class II | |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | Acon Laboratories, Inc. | NBW | Class II | |
| K243815 | SoClean 3+ | SoClean, Inc. | QXQ | Class II | |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International Inc. | DZE | Class II | |
| K253094 | iFuse Bedrock Granite Implant System | SI-Bone, Inc. | OUR | Class II | |
| K252939 | Cohitech Organic Cotton Compact Applicator Tampons | Cotton High Tech S.L. | HEB | Class II | |
| K252911 | Lux HD 2530 detector (Lux HD 2530) | iRay Imaging Technology (Haining) Limited | MQB | Class II | |
| K252910 | Orca Air/Water and Suction Valves | Boston Scientific Corporation | ODC | Class II | |
| K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | NXC | Class II | |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | NFT | Class II | |
| K252600 | Pediatric Plating Platform I Small-Mini | Orthopediatrics Corp | HRS | Class II | |
| K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | NFO | Class II | |
| K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K251876 | cleadew GP hydra one | Ophtecs Corporation | MRC | Class II | |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | HONSUN (NANTONG) Co., Ltd. | DXN | Class II | |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corp. | OLT | Class II | |
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical Ltd | FER | Class II | |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | KTI | Class II | |
| K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | DYB | Class II | |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics GmbH | SET | Class II | |
| K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. | GEX | Class II | |
| K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K251363 | ProKnow DS | Elekta Solutions AB | LLZ | Class II | |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | Unclassified | |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | HWC | Class II | |
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) | Clinical Innovations, LLC | HDB | Class II | |
| K250060 | Gt300; Gt300-C | Genoray Co., Ltd. | OAS | Class II | |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | |
| K252851 | deepLive (OSP12 + DMS) | Damae Medical | NQQ | Class II |