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 |
|---|---|---|---|---|---|
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | NBC | Class II | |
| K241113 | Vivix-M | Vieworks Co., Ltd. | MUE | Class II | |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems Inc | QEP | Class II | |
| K233770 | Pepper EMS Training System | Pepper Interactive Inc | NGX | Class II | |
| K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | NKB | Class II | |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | PZX | Class II | |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | JPA | Class II | |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech LLC | LCX | Class II | |
| K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | Trimed Inc | HRS | Class II | |
| K243328 | Ziehm Vision RFD | Ziehm Imaging GmbH | OWB | Class II | |
| K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | PLQ | Class II | |
| K243065 | Cardiac Guidance | Caption Health | QJU | Class II | |
| K242936 | Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Sunray Medical Products Inc. | LZA | Class I | |
| K242935 | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | BZD | Class II | |
| K242873 | Ventrax™ Delivery System | Merit Medical Systems, Inc. | DQY | Class II | |
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International | NVP | Class II | |
| K242634 | PuraStat | 3-D Matrix Europe SAS | PHN | Unclassified | |
| K242541 | Gem Zipclip | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | FZP | Class II | |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | DRE | Class II | |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid | QQX | Class II | |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co., Ltd | GXY | Class II | |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | JOW | Class II | |
| K243904 | Elegance® Anterior Cervical plate | Clariance, Inc. | KWQ | Class II | |
| K243577 | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | QJP | Class II | |
| K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | OXO | Class II | |
| K243297 | APRO 70 Swift Catheter | Alembic LLC | QJP | Class II | |
| K243272 | LOCATOR Angled Abutment | Zest Anchors LLC | NHA | Class II | |
| K242672 | Zoom System | Imperative Care Inc. | NRY | Class II | |
| K242205 | SpectoMed (v1.0) | Specto Medical AG | LLZ | Class II | |
| K241278 | ASEPT® Glide Peritoneal Drainage System | PFM Medical GmbH | PNG | Class II | |
| K241180 | Consensus Knee System with TiNbN | Shalby Advanced Technologies, Inc. | JWH | Class II | |
| K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K241066 | Bb-613-Bpm | Biobeat Technologies Ltd | DXN | Class II | |
| K241037 | ABL90 FLEX PLUS System | Radiometer Medicals ApS | CEM | Class II | |
| K243950 | ARVIS® Shoulder | Kico Knee Innovation Company | SBF | Class II | |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Alcon Laboratories | LPL | Class II | |
| K243890 | Arthrex Intramedullary Nails | Arthrex GmbH | HSB | Class II | |
| K243791 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co.,Ltd | IRP | Class II | |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | HLB Co., Ltd. Healthcare | FMK | Class II | |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corp. | HIF | Class II | |
| K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | JWH | Class II | |
| K243271 | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | Mentor Worldwide, LLC | MRD | Unclassified | |
| K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC | SCA | Class II | |
| K242689 | AAMI Level 4 Protective; Gown | AZAC Group | QPC | Class II | |
| K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (dba Letsgetchecked) | FMK | Class II | |
| K242030 | MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. | NHA | Class II | |
| K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta Ltd. | JAK | Class II | |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho SpA | LPH | Class II | |
| K233452 | Vivo 45 LS | Breas Medical AB | NOU | Class II |