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 |
|---|---|---|---|---|---|
| K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | PHX | Class II | |
| K223718 | HandX™ Self-Righting Needle Holder | Human Xtensions, Ltd. | GCJ | Class II | |
| K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | LGZ | Class II | |
| K221752 | Stella | Shinhung MST Co., Ltd. | DZE | Class II | |
| K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | PBF | Class II | |
| K231311 | CPS Direct™ Universal slittable outer guide catheter (DS2C029) | Abbott Medical | DQY | Class II | |
| K231309 | Scar 3 | El.En Electroinc Engineering SpA | GEX | Class II | |
| K230971 | APTUS® 3.5 TriLock Straight Plates | Medartis AG | HRS | Class II | |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | Howmedica Osteonics Corp., dba Stryker Orthopaedics | JWH | Class II | |
| K230936 | Anatomic PEEK™ Cervical Fusion System with Nanotechnology | Nanovis, LLC | ODP | Class II | |
| K230888 | Titanium Turbine | Nakanishi Inc. | EFB | Class I | |
| K230635 | Pen Needle | Jiangsu Caina Medical Co., Ltd | FMI | Class II | |
| K230214 | Huma RPM (RPM) | Medopad, Inc. | MWI | Class II | |
| K223822 | Activbraid™ | Embody, Inc. | GAT | Class II | |
| K223562 | Xpan Universal Trocar System | Xpan, Inc. | GCJ | Class II | |
| K223074 | CorNeat EverPatch | Corneat Vision, Ltd. | QWU | Class II | |
| K222961 | Harvest Conceal ZR Block Out | Harvest Dental Products LLC | EIH | Class II | |
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | I3 Membrane Corporation | NHV | Class II | |
| K222702 | RGS; RGS Mini | Genesis Air, Inc. | FRA | Class II | |
| K222018 | Breathe+ | Peep Medical, LLC dba Go2 Devices | BWF | Class II | |
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Siemens Healthcare Diagnostics Inc. | PQO | Class II | |
| K220728 | vWF Ag | Siemens Healthcare Diagnostics Products Limited | GGP | Class II | |
| K220301 | Volumat Line | Fresenius Kabi AB | FPA | Class II | |
| DEN220041 | Tristel Duo ULT | Tristel Solutions, Ltd. | QWS | Class II | |
| K231330 | FiberTak® Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems Inc | QQX | Class II | |
| K231293 | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics, Ltd. | DQO | Class II | |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | Candela Corporation | GEX | Class II | |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | JTN | Class II | |
| K230617 | Surgical Face Mask (L 175*95mm) | Henan Chaoya Medical Equipment Co., Ltd. | FXX | Class II | |
| K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | Sb-Kawasumi Laboratories, Inc. | JKA | Class II | |
| K230185 | ANT-X System | Ndr Medical Technology Pte., Ltd. | OWB | Class II | |
| K223929 | Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) | Innova Vascular, Inc. | QEW | Class II | |
| K223676 | SomniCheck | Brainmatterz, Inc | GWL | Class II | |
| K223555 | Brainomix 360 e-CTP | Brainomix Limited | LLZ | Class II | |
| K223498 | Radius VSM and Accessories | Masimo Corporation | MHX | Class II | |
| K223447 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung | JAK | Class II | |
| K223299 | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance | Ambu A/S | EOQ | Class II | |
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) | Ningbo Maxcon Medical Technology Co., Ltd | MMK | Class II | |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | MAI | Class II | |
| K231259 | iRoot SP Plus | Innovative BioCeramix, Inc | KIF | Class II | |
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros Ltd | FTL | Class II | |
| K230542 | Disposable Nitrile Gloves (ABC-DG01) | Huizhou Anboson Technology Co., Ltd. | LZA | Class I | |
| K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | Pegavision Corporation | LPL | Class II | |
| K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, LLC | CBK | Class II | |
| K222556 | Btl-785X | BTL Industries, Inc | GEI | Class II | |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | Medline ReNewal | NLH | Class II | |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | FJK | Class II | |
| K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co.,Ltd. | QNQ | Class II | |
| K211056 | Oxus Sieve Beds | Oxus, Inc. | CAW | Class II |