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 |
|---|---|---|---|---|---|
| K230906 | Konicaminolta DI-X1 | Konica Minolta, Inc. | LLZ | Class II | |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | PDU | Class II | |
| K230549 | IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG | Shenzhen Xiazhifeng Electronic Co., Ltd | OHT | Class II | |
| K230503 | Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable | Boston Scientific Corporation | DRF | Class II | |
| K230223 | iCAC Device | Bunkerhill, Inc. | JAK | Class II | |
| K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | Dental Direkt GmbH | NHA | Class II | |
| K230204 | ALPHALOK Plating System | Vilex LLC | HRS | Class II | |
| K230202 | TMINI™ Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K230056 | MiVu™ Esophageal Endo Cap | Diversatek Healthcare Inc | QIS | Class II | |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | KRA | Class II | |
| K222676 | Ceevra Reveal 3 | Ceevra, Inc. | QIH | Class II | |
| K220513 | NITRO Interbody Fusion Cage System Family | CTL Medical Corporation | ODP | Class II | |
| K230704 | RAIN Sheath™ Tibial Pedal Introducer | Cordis US Corp. | DYB | Class II | |
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | MWP | Class II | |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | MWP | Class II | |
| K230103 | Klockner Abutments | Soadco, S.L. | NHA | Class II | |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | LZG | Class II | |
| K223141 | STR8 Clear Aligner | Str8 Oral Care | NXC | Class II | |
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | MOF | Class II | |
| K222330 | The Heart Seat | Casana Care, Inc. | MWI | Class II | |
| K220274 | Kisar Stratford SI Screw System | Anjali Investments L.L.C | OUR | Class II | |
| K220261 | NEST-C Interbody System | Paonan Biotech Co., Ltd | ODP | Class II | |
| K230819 | OmniGuide RFID Surgical Laser Fibers | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | ONF | Class II | |
| K230811 | Digital Intraoral X-Ray Sensor | iRay Imaging Technology (Haining) Limited | MUH | Class II | |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | OVD | Class II | |
| K230789 | Knee+ | Pixee Medical | SBF | Class II | |
| K230783 | Anatase Spine Surgery Navigation System | Remex Medical Corp. | OLO | Class II | |
| K230468 | EzDent Web | Ewoosoft Co., Ltd | LLZ | Class II | |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K223501 | ViewFinder Software Version 1.1 | Elaitra, Ltd. | QIH | Class II | |
| K223300 | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument | Geotek Medikal Ltd Sti | KNW | Class II | |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., dba Stryker Orthopaedics | KRO | Class II | |
| K222604 | dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S | Dentona AG | MQC | Unclassified | |
| K222291 | Paradigm System | Proprio | OLO | Class II | |
| K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | GDW | Class II | |
| K221742 | Conneqt Pulse | ATCOR MEDICAL Pty Ltd | DXN | Class II | |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | HRX | Class II | |
| K230807 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | JAK | Class II | |
| K230785 | Precision1, Precision1 for Astigmatism | Alcon Laboratories | LPL | Class II | |
| K230565 | HILINE™ Fixation System | Globus Medical, Inc. | OWI | Class II | |
| K223768 | RadiForce RX270 | Eizo Corporation | PGY | Class II | |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K223287 | Velacur | Sonic Incytes | IYO | Class II | |
| K223238 | STARband 3D | Orthomerica Products, Inc. | MVA | Class II | |
| K222261 | Flexible Video-Choledochoscope System | Shanghai Seegen Photoelectric Technology Co., Ltd | FBN | Class II | |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | QEY | Class II | |
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | DWP | Class II | |
| K212220 | ArtFX Spinal Fixation System | Artfx Medical LLC | NKB | Class II | |
| K211153 | Inomax DSIR | Mallinckrodt Manufacturing LLC | MRN | Class II |