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 |
|---|---|---|---|---|---|
| K240376 | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | OAB | Class II | |
| K240074 | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) | Shenzhen Besdata Technology Co.,Ltd | FGB | Class II | |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. | FRN | Class II | |
| K242616 | Lantern® Hip | OrthAlign, Inc. | ONN | Class II | |
| K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific Corporation | KRD | Class II | |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | KIF | Class II | |
| K241472 | Icona Hip Stem | Corin USA | MEH | Class II | |
| K240808 | Pulse Oximeter (WS20A) | Hunan Accurate Bio-Medical Technology Co., Ltd. | DQA | Class II | |
| K240586 | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales MedTech Co., Ltd. | ELL | Class II | |
| K240393 | Exactech® TRULIANT® Knee System | Exactech, Inc. | MBH | Class II | |
| K233497 | Rest Assure System | Somnomed Inc. | PLC | Class II | |
| K242613 | NxTAG® Respiratory Pathogen Panel | Luminex Molecular Diagnostics Inc | OCC | Class II | |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Osteoremedies, LLC | JWH | Class II | |
| K242302 | RejuvaKnee™ Collagen Meniscus Implant | Collagen Matrix, Inc | OLC | Class II | |
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | GE Healthcare | IYN | Class II | |
| K241925 | VitruvianScan (v1.0) | Perspectum Ltd. | LNH | Class II | |
| K241907 | Anovo Surgical System (model 6N) | Momentis Surgical Ltd. | QNM | Class II | |
| K241561 | MammoScreen BD | Therapixel | QIH | Class II | |
| K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group | OVD | Class II | |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex GmbH | QHE | Class II | |
| K240889 | ARTFX Lumbar PEEK Cages | Artfx Medical LLC | MAX | Class II | |
| K240529 | 8F Modified Sheath System | Route 92 Medical, Head Quarters | QJP | Class II | |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co.,Ltd | KLE | Class II | |
| K242678 | Definium Pace Select ET | GE Hualun Medical Systems Co., Ltd. | KPR | Class II | |
| K242651 | Gm85 | Samsung Electronics Co., Ltd. | IZL | Class II | |
| K242498 | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | Aicheck Biotech, Inc. | NFT | Class II | |
| K242277 | Crown HT | Sprintray Inc. | EBF | Class II | |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Thermo Fisher Scientific Oy | JWY | Class II | |
| K241331 | MuscleView | Springbok, Inc. | LNH | Class II | |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton Shanghai Medical Instruments Co Ltd | ODC | Class II | |
| K240943 | LungVision | Bodyvision Medical, Ltd. | QIH | Class II | |
| K240917 | Esperance 3+ Aspiration Catheter System | Wallaby Medical | NRY | Class II | |
| K240331 | Electric wheelchair (YHWL002, YHWL003) | Yongkang Youha Electric Appliance Co., Ltd. | ITI | Class II | |
| K242276 | CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. | DQY | Class II | |
| K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort Neurotech (Shanghai) Co., Ltd. | HCG | Class II | |
| K241952 | AQUABEAM Robotic System (AB2000) | PROCEPT BioRobotics Corporation | PZP | Class II | |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | JOJ | Class II | |
| K241657 | Msfx Mikron Spinal Fixation System | Mikron Makina Sanayi ve Ticaret Ltd. Sti. | NKB | Class II | |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. | QYT | Class II | |
| K241151 | Luxen 5G | Dentalmax Co., Ltd | EIH | Class II | |
| K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | CGA | Class II | |
| DEN230011 | OcuCool | Recensmedical Inc. | QZQ | ||
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | HCG | Class II | |
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 | Hyundae Meditech Co., Ltd. | NEW | Class II | |
| K242557 | ClotTriever XL Catheter (41-102) | Inari Medical, Inc. | QEW | Class II | |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co.,Ltd | NFT | Class II | |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | PPN | Class II | |
| K242206 | Activo | Daeju Meditech Engineering Co., Ltd. | GEX | Class II | |
| K242125 | Elvie Stride 2 | Chiaro Technology Limited | HGX | Class II | |
| K241939 | EasyCare Tx 2 | ResMed Corp | BZD | Class II |