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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K972556 | Quickscreen One Step Methamphetamine Test(9065) | Phamatech Inc. | LAF | Class II | |
| K972113 | 30 Cc and 40 Cc Sub-9 Nitinol and 30 and 40 Cc Sub-9 Stainless Steel | Boston Scientific Corporation | DSP | Class II | |
| K972103 | Philips Easyvision | Philips North America LLC | LLZ | Class II | |
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay Kit | Diagnostic Specialties | JIQ | Class I | |
| K972976 | Cardiac Markers Control - Level 1, Level 2, Level 3, Tri-Level | More Diagnostics Inc. | JJT | Class I | |
| K972748 | Cards Q.s. Hcg-Urine; and Concise Performance Plus Hcg-Urine | Ortho-Clinical Diagnostics, Inc. | JHI | Class II | |
| K972742 | Quickvue One-Step Hcg-Urine | Ortho-Clinical Diagnostics, Inc. | JHI | Class II | |
| K972606 | Pregnacol Pregnancy Test | Immunostics, Inc. | JHJ | Class II | |
| K972586 | Aia-Pack Tsh 3Rd-Gen Assay | Tosoh Medics, Inc. | JLW | Class II | |
| K972583 | Uresil General Purpose Drainage Catheter, Uresil Nephrostomy Catheter, Uresil Biliary Catheter, Uresil Nephro-Ureteral S | Uresil, LLC | FGE | Class II | |
| K972421 | Easy Bond | Parkell, Inc. | KLE | Class II | |
| K972414 | Freshcells | Ortho-Clinical Diagnostics, Inc. | KIR | Class I | |
| K972411 | Link Cement Plug | Turnkey Intergration USA, Inc. | LZN | Class II | |
| K972403 | Bti Cortical Bone Screws | Biodynamic Technologies, Inc. | HWC | Class II | |
| K972355 | 3M Aurora System | 3M Company | EBZ | Class II | |
| K972279 | Sharps Shuttle | Sage Products LLC | FMI | Class II | |
| K972122 | Dream Catcher | Rest Technologies, Inc. | GXY | Class II | |
| K972115 | Volker Hospital Bed, Model K960 | Volker Healthcare, Inc. | FNL | Class II | |
| K972091 | Ams Foreign Body Extrator | American Medical Systems, Inc. | FFL | Class II | |
| K972055 | Msi Magna-Stym | Microvas Systems, Inc. | IPF | Class II | |
| K972035 | Sporox Test Strips | Serim Research Corp. | JOJ | Class II | |
| K971998 | Advia 120 Hematology System, in Vitro Diagnostic System | Bayer Corp. | GKL | Class II | |
| K971219 | Cryo Check Inr Validation Set | Precision Biologicals, Inc. | GGN | Class II | |
| K971200 | W.a. | W.A. Rubbermate Co., Ltd. | LYY | Class I | |
| K971102 | Ambiderm | Supertex Industrial, S.A. de C.V. | LYY | Class I | |
| K970347 | Mpc (Model 7000) External Temporary Pacemaker System | Paladin Medical, Inc. | DTE | Class II | |
| K970296 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter | Boston Scientific Corporation | MCW | Class II | |
| K970072 | Opus S Model 4121 and 4124 Pacemakers | Ela Medical, Inc. | DXY | Class III | |
| K964799 | Artrotherm Cryotherapy and Thernotherapy | Ormed GmbH | ILO | Class II | |
| K964354 | Artocool-S Water Circulating Cold Pack | Ormed GmbH | ILO | Class II | |
| K962167 | Bronchial Blocker | Cook Inc. | CBI | Class II | |
| K960756 | Lifetech Cassette | Lifetech Systems, Inc. | KPJ | Class II | |
| K972942 | Aurecast 83 | Aurex Precious Metal Industries (Pty)Ltd | EJT | Class II | |
| K972941 | Aurecast 74 | Aurex Precious Metal Industries (Pty)Ltd | EJT | Class II | |
| K972868 | Trademark Blood Gas/electrolyte/glucose, Lactate, Bun and Creatinine Control | Bionostics, Inc. | JJY | Class I | |
| K972835 | 50Ng/ml Cocaine Metabolite Calibrator | Diagnostic Reagents, Inc. | DLJ | Class II | |
| K972812 | Raichem Prealbumin Spia | Hemagen Diagnostics, Inc. | DDS | Class I | |
| K972467 | Sterile Water for Inhalation, Usp | Holopack International, LP | CAF | Class II | |
| K972466 | Sodium Chloride Inhalation Solution, Usp | Holopack International, LP | CAF | Class II | |
| K972409 | Ag Chemistry Analyzer System | Landmark Scientific, Inc. | JJG | Class I | |
| K972359 | Remel Bile Esculin Azide Agar W/6 Mcg/ml Vancomycin | Remel Inc | JSO | Class II | |
| K972175 | Infusasleeve Iia (Is-2A) | Localmed, Inc. | QEY | Class II | |
| K972059 | Quikpac II One Step Cocaine Test | Drial Consultants, Inc. | DIO | Class II | |
| K971499 | Female External Urinary Collection Pouch | Mediquest, Inc. | EXI | Class I | |
| K970769 | Comsat Adult,pediatric,infant,neonatal,disposable Sensor/comsat Reusable Finger Sensor | Aristo Medical | DQA | Class II | |
| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing Electrode | Graphic Controls Corp. | MKJ | Class III | |
| K972628 | Thermogard & Thermogard Plus Abc | Conmedcorp | GEI | Class II | |
| K972497 | Karl Storz Monopolar Coagulating Electrodes/ Karl Storz Monopolar Coagulating Needle Electrodes | Karl Storz Endoscopy-America, Inc. | GEI | Class II | |
| K972469 | Selfshield Hn Self Sheathing Hypodermic Needle | Beech Medical Products, Inc. | FMI | Class II | |
| K972299 | Bergen Model 500 Electrosurgery Generator | Bergen Mfg. | GEI | Class II |