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 |
|---|---|---|---|---|---|
| K252539 | Tempus Pixel | Arterys Inc. | QIH | Class II | |
| K252454 | Kinos Total Ankle System | restor3d, Inc. | HSN | Class II | |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K252174 | AquaCast Mask | Blessing Cathay Corporation | IYE | Class II | |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | NFO | Class II | |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | OMC | Class II | |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine, Inc. | OVD | Class II | |
| K251457 | Diode laser therapy device (VADER) | Beijing Superlaser Technology Co., Ltd. | GEX | Class II | |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | DXQ | Class II | |
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | Dongguan e-Test Technology Co.,Ltd | DXN | Class II | |
| K250217 | AGNES Ultra | Agnes Medical Co.,Ltd | GEI | Class II | |
| K231952 | Medilight | Medicreations LLC | ONF | Class II | |
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion | NJD | Class II | |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | EMA | Class II | |
| K251615 | Aerogen Pro-X1 Controller System | Aerogen Ltd. | SFP | Class II | |
| K251408 | OsteoSight™ Hip (v1) | Naitive Technologies Ltd | SAO | Class II | |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni | MYN | Class II | |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Boblingen GmbH | MHX | Class II | |
| K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | NHA | Class II | |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze | NRY | Class II | |
| K252380 | Invisalign System | Align Technology, Inc. | NXC | Class II | |
| K252364 | Edwards eSheath Optima introducer set | Edwards Lifesciences LLC | DYB | Class II | |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | HWC | Class II | |
| K251946 | G aenial Universal Injectable II | GC America Inc. | EBF | Class II | |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte., Ltd. | FPA | Class II | |
| K251727 | GLAM LED Facial Mask (TB-2386F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd | GEX | Class II | |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.p.A. | LPH | Class II | |
| K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | SFK | Class II | |
| K251324 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic, Inc. | QJI | Class II | |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | Merit Medical Ireland, Ltd | DQX | Class II | |
| K251108 | Erbe ESU Model VIO® 3n with Accessories | ERBE Elektromedizin GmbH | GEI | Class II | |
| K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K251026 | Regenesis EMS Chair | Trinity Medical Solutions, LLC | KPI | Class II | |
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | HET | Class II | |
| K250874 | Sunrise | Sunrise SA | QRS | Class II | |
| K250771 | Primescan 2 | Dentsply Sirona Inc | NTK | Class II | |
| K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting Corp. | ODP | Class II | |
| K250290 | SurgiTwin | Twinsight | LLZ | Class II | |
| K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S (091678-003); Neurovent-P-Temp (094268-003); Neurovent-Temp (094278-003); Neurovent-Temp-Ifd-R (095327-003); Neurovent-Temp-Ifd-S (094288-003); Neurovent-Pto (095008-003); Neurovent-Pto 2L (095108-003); Neurovent-Px (091580-003); Bolt-Drill Kit Ch5 (091888-003); Bolt-Drill Kit Ch9 (091898-003); Bolt-Drill Kit Pto (092380-003); Bolt-Drill Kit Vp 16 (092969-003); Bolt Kit Ch5 (091868-003); Bol | Raumedic AG | GWM | Class II | |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology Inc. | PZM | Class II | |
| K243859 | PRAEVAorta®2 | Nurea | QIH | Class II | |
| K243799 | Fetal Pillow | CooperSurgical, Inc. | PWB | Class II | |
| K243745 | FG Bone Graft B | Full Golden Biotech Co., Ltd. | LYC | Class II | |
| K252505 | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology Inc. | LYZ | Class I | |
| K252437 | JAZZ Spinal System | Implanet | NKB | Class II | |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | PHX | Class II | |
| K252383 | Somfit D | Compumedics Limited | MNR | Class II | |
| K252350 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | |
| K252057 | Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System | Imperative Care Inc. | QEW | Class II |