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 |
|---|---|---|---|---|---|
| K252096 | Light Therapy Decollete Mask (1019135) | Merchsource LLC | OHS | Class II | |
| K251899 | E Blator | New Deantronics Taiwan Ltd. | GEI | Class II | |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHS | Class II | |
| K251767 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp. | LYK | Class II | |
| K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | QEP | Class II | |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | |
| K250083 | PRO-DOSE System | Nu-Rise, SA | NZT | Class II | |
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | Wuxi Hisky Medical Technologies Co., Ltd. | IYN | Class II | |
| K252722 | Biopsy Forceps | FEHLING INSTRUMENTS GmbH | DWZ | Class II | |
| K252106 | External Fixation Mini Rail System | Paragon 28 | KTT | Class II | |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker) | MQV | Class II | |
| K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | SGA | Class II | |
| K251799 | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | INI | Class II | |
| K251690 | Arthrex SpeedFLEX™ Implant | Arthrex GmbH | OWY | Class II | |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. | DSA | Class II | |
| K251197 | Dexter L6 System | Distalmotion SA | SDD | Class II | |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | IYO | Class II | |
| K250050 | miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV | PGH | Class II | |
| K243270 | TigerConnect Alarm Management | Tigerconnect | MSX | Class II | |
| K253236 | G-Block | Graphenano Dental, SL | EBF | Class II | |
| K252770 | iLet ACE Pump | Beta Bionics, Inc. | QFG | Class II | |
| K252594 | UltraGuideCTR® image guided soft tissue release system | SONEX HEALTH, Inc | HRX | Class II | |
| K252441 | Primero Safe Access System | SOUTH53 | DYB | Class II | |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater Inc | SBF | Class II | |
| K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics | SBG | Class II | |
| K251334 | New Doublo 2.0 | Hironic Co., Ltd. | GEI | Class II | |
| K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical Inc. | KNS | Class II | |
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager & Meisinger GmbH | DZL | Class II | |
| K250023 | Smart Pcfd | Disior Oy | QIH | Class II | |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions Ltd | DZE | Class II | |
| K243833 | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | CAW | Class II | |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | BWH | Class II | |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | HCG | Class II | |
| K252435 | Magnetic Surgical System | Levita Magnetics International Corp. | PNL | Class II | |
| K252221 | Inset Reverse Total Shoulder System | SHOULDER INNOVATIONS, Inc | PHX | Class II | |
| K252105 | Ligence Heart | Ligence UAB | QIH | Class II | |
| K251986 | Auxiliary Water Tube Maj-855 | Olympus Medical Systems Corp. | OCX | Class II | |
| K251919 | Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co.,Ltd. | GEX | Class II | |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation | JAK | Class II | |
| K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | DXG | Class II | |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K251208 | Tuned Self-Fitting Mobile App | Tuned, Ltd. | SCR | Class II | |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | FDA | Class II | |
| K250659 | LoFric Origo | Wellspect Inc. | EZD | Class II | |
| K250318 | Planmed XFI | Planmed Oy | SFV | Class II | |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | BZQ | Class II | |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corp. | JWH | Class II | |
| K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K252102 | Alinity m HCV | Abbott Molecular, Inc. | MZP | Class II | |
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | Wuhan DIMED LASER TECHNOLOGY CO., Ltd. | GEX | Class II |