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 |
|---|---|---|---|---|---|
| K172556 | TubeClear System | Actuated Medical, Inc. | KNT | Class II | |
| K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | PZX | Class II | |
| K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | Varian Medical Systems, Inc. | IYE | Class II | |
| K181203 | Juliet Ti | Spineart SA | MAX | Class II | |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | KOD | Class II | |
| K181121 | Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro | Home Well Trading, Ltd. | OHT | Class II | |
| K180993 | Beacon Advanced CO2 Laser System | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | LOX | Class II | |
| K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics Ltd. | GXY | Class II | |
| K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | Ethicon, Inc | FTL | Class II | |
| K180729 | FaSet Fixation System | Huvexel Co., Ltd. | MRW | Unclassified | |
| K180583 | Logic 4K Camera Controller, Logic 4K Camera Head | Richard Wolf Medical Instruments Corp. | FET | Class II | |
| K180562 | Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon, Try-in, Burnout, Try-in & Burnout | Zirkonzahn SRL | EBG | Class II | |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | Ethicon, Inc | PWJ | Class II | |
| K173116 | KJ ZIRCONIA Implant System | KJ Meditech Co., Ltd. | DZE | Class II | |
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | DPW | Class II | |
| K181413 | uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery, Inc. | OCW | Class II | |
| K180895 | Alleye | Oculocare Medical AG | HOQ | Class I | |
| K180858 | CALLISTO eye | Carl Zeiss Meditec Inc | NFJ | Class II | |
| K180720 | Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel | Medibio USA LLC | FMI | Class II | |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | Halyard Health | LZC | Class I | |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | PPN | Class II | |
| K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | ODP | Class II | |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | |
| K181119 | Range (Denali and Mesa) Spinal Systems | K2M, Inc | NKB | Class II | |
| K180769 | SecurAcath | Interrad Medical Inc | OKC | Class II | |
| K173856 | Express 4 Sleep appliance/CPAP Sidekick appliance | Moses Appliances, LLC | LRK | Class II | |
| K173725 | NeuMoDx GBS Assay | Neumodx Molecular, Inc. | NJR | Class I | |
| K173574 | DenSeeMammo | Statlife | LLZ | Class II | |
| K173361 | IV Administration Set | B.Braun Medical, Inc. | FPA | Class II | |
| K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | LKF | Class II | |
| K181465 | SpaceOAR System | Augmenix, Inc. | OVB | Class II | |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB | MSV | Class II | |
| K181230 | Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA | Largan Medical Co., Ltd. | LPL | Class II | |
| K180995 | Vscan Extend | GE Healthcare | IYN | Class II | |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | LLL | Class II | |
| K180724 | SPIRA Open Matrix LLIF | Camber Spine Technologies | MAX | Class II | |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | GAP | Class II | |
| K180690 | Navigation Instruments | Globus Medical, Inc. | OLO | Class II | |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | Cutting Edge Spine | ODP | Class II | |
| K172788 | MONET™ Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | ODP | Class II | |
| K181492 | Elecsys CA 15-3 II | Roche Diagnostics GmbH | MOI | Class II | |
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | Sekisui Diagnostics, LLC | KTN | Class II | |
| K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm | Shape Memory Medical Inc | KRD | Class II | |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) | Terumo Cardiovascular Systems Corporation | DTZ | Class II | |
| K180824 | VaPro 2 Intermittent Catheter | Hollister Incorporated | GBM | Class II | |
| K180815 | MIM - SPECTRA Quant | MIM Software Inc | LLZ | Class II | |
| K180785 | iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | |
| K180594 | Knotless SutureTak Anchors | Arthrex GmbH | MAI | Class II |