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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180667 | SmartGrid | Eastman Kodak Company | MQB | Class II | |
| K180408 | U60 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | |
| K180305 | Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) | Aquilabs Us, LLC | FRO | Unclassified | |
| K173934 | Reza Band, Reflux Band | Somna Therapeutics, LLC | PKA | Class II | |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | ISA | Class I | |
| K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | OVD | Class II | |
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec Inc | HNO | Class I | |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | Cook Incorporated | MQF | Class II | |
| K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand) Ltd. | LZA | Class I | |
| K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH | ELW | Class II | |
| K171326 | Piezosurgery White | Mectron S.p.A. | DZI | Class II | |
| K170901 | Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, Ba400 | Biosystems S.A. | CIX | Class II | |
| K170761 | LIGHTSonic BUBM | Light-Med (USA), Inc. | IYO | Class II | |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | I-SENS, Inc. | JIN | Class I | |
| K162499 | Best Instruminal Applicator | Best Medical International, Inc. | JAQ | Class II | |
| K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire | Boston Scientific Corporation | DQX | Class II | |
| K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device | STERIS Corporation | PKL | Class II | |
| K180666 | 48CH Head Coil | GE Healthcare Coils (USA Instruments, Inc.) | MOS | Class II | |
| K180651 | Uroview FD II | PAUSCH Medical GmbH | JAA | Class II | |
| K180567 | C3 Wave System | Medical Components, Inc. | LJS | Class II | |
| K180549 | ZED Link | Zed Technologies | LLZ | Class II | |
| K173515 | Admiral Xtreme | Medtronic, Inc. | LIT | Class II | |
| K172315 | Straub Endovascular System | Straub Medical AG | MCW | Class II | |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics Inc. | CGN | Class II | |
| K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC | QSY | Unclassified | |
| K180744 | Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, Inc | KYI | Class II | |
| K180318 | PET Digital Gating | GE Healthcare | KPS | Class II | |
| K180121 | Rafugen DBM | Cellumed Co., Ltd. | MQV | Class II | |
| K173880 | Corin TriFit CF Hip Stem | Corin USA | MEH | Class II | |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System | Volcano Corporation | IYO | Class II | |
| K173859 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | MAI | Class II | |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | Cook Incorporated | MQF | Class II | |
| K172495 | Reform® POCT System | Precision Spine, Inc. | NKG | Class II | |
| K172187 | Inno-Hydrowire | Suzhou Innomed Medical Device Co., Ltd. | DQX | Class II | |
| K172047 | Riva Star | Sdi Ltd. | PHR | Class II | |
| DEN180001 | IDx-DR | Idx, LLC | PIB | Class II | |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | KOD | Class II | |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal | Alcon Laboratories | LPL | Class II | |
| K180301 | AXIS 5.5 Lumbar Pedicle Screw System | Axis Orthopaedics | NKB | Class II | |
| K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | Johnson & Johnson Vision Care, Inc. | LPL | Class II | |
| K180233 | Eviva Stereotactic Guided Breast Biopsy System | Hologic, Inc. | KNW | Class II | |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | Smiths Medical Ads, Inc. | BTO | Class II | |
| K172967 | Mercury® Spinal System | Spinal Elements, Inc | NKB | Class II | |
| K172206 | NAJA™ Ligament Correction System | Cousin Biotech SAS | OWI | Class II | |
| K171379 | Digital Automatic Wrist Blood Pressure Monitor MD4300 | Grandway Technology (Shenzhen) Limited | DXN | Class II | |
| K170776 | Dti-1 Sla Implant System | Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi | DZE | Class II | |
| DEN170001 | Precision Flow® HVNI | Vapotherm Inc. | QAV | Class II | |
| K180372 | Aurora Evacuator | Rebound Therapeutics, Corporation | GEI | Class II |