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 |
|---|---|---|---|---|---|
| K955521 | Alpha-Dent Copal Cavity Varnish | Wallace A. Erickson & Co. | LBH | Class II | |
| K955498 | Cholinesterase Assay Kit, Catalogue# 300-05 | Sekisui Diagnostics P.E.I. Inc. | DIH | Class I | |
| K955494 | Gore-Tex Dualmesh Biomaterial with Holes | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K955436 | Access Vitamin B12 Assay (Modification) | Bio-Rad Laboratories Inc. | CDD | Class II | |
| K955435 | Access Total T3 Assay (Modification) | Bio-Rad Laboratories Inc. | CDP | Class II | |
| K955354 | Alternative Sterilization Process | Howmedica Corp. | JDI | Class II | |
| K955285 | Galloy | Southern Dental Industries, Inc. | EJJ | Class II | |
| K955184 | Acculupe | E for M Imaging Systems Div., Marquette Electronic | LMB | Class I | |
| K955163 | Dissection Probe | Origin Medsystems, Inc. | GEI | Class II | |
| K955151 | Maxi-Flow Suction Tube/top Gun Suction Irrigator | Bio-Medical Devices, Inc. | BYY | Class II | |
| K955149 | Maxi-Flow Suction Handle/the Reel Thing Tubing Reel | Bio-Medical Devices, Inc. | BYY | Class II | |
| K955065 | Olympus Fb Series Biopsy Forceps | OLYMPUS Corporation of the Americas | FCL | Class I | |
| K955052 | Olympus Fd-1/2-1 Hot Biopsy Forceps | OLYMPUS Corporation of the Americas | KGE | Class II | |
| K954997 | Centocor Aggrestat, Collagen Reagent, Control Reagent | Centocor, Inc. | JOZ | Class II | |
| K954972 | Lyell Sound | Venture Management Corp. | FBS | Class I | |
| K954928 | Portable Reverse Osmosis Machine | Better Water, Inc. | FIP | Class II | |
| K954911 | Omega Ultrascan | Gyne-Tech Instrument Corp. | GEX | Class II | |
| K954887 | Sterile Water O.9% Sterile Saline | Lockett Medical Corp. | FOZ | Class II | |
| K954838 | Ez Fix | Biodynamic Technologies, Inc. | JEC | Class II | |
| K954749 | Mallinckrodt Shiley 15Mm Cap | Mallinckrodt Medical | JOH | Class II | |
| K954332 | Rbcfolate Assay for the Technicon Immuno 1 System | Bayer Corp. | CGN | Class II | |
| K954276 | Stealthstation | Surgical Navigation Technologies, Inc. | HAW | Class II | |
| K954119 | Miracle Ear Mirage | Miracle-Ear, Inc. | ESD | Class I | |
| K953500 | Hemo-Barrier | Asia Dynamics Inc. | KMF | Class I | |
| K952557 | Total T-3 Fpia Reagent Set, Total T-3 Fpia Calibrators | Sigma Diagnostics, Inc. | CDP | Class II | |
| K946217 | Cardiolipin M Eia Test System | Hogan & Hartson | MID | Class II | |
| K946216 | Cardiolipin a Eia Test System | Hogan & Hartson | MID | Class II | |
| K946215 | Cardiolipin G Eia Test System | Hogan & Hartson | MID | Class II | |
| K946207 | Conqueror, Rumba and Temptation | Frontline Latex Products Pvt., Ltd. | HIS | Class II | |
| K955463 | Grip-a-Boots | Sil-Med Corp. | LXZ | Class I | |
| K955372 | Ball Attachment System | Nobelpharma USA, Inc. | DZE | Class II | |
| K955369 | Memfix | Straumann USA, LLC | DZL | Class II | |
| K955337 | Opaker | Kerr Dental Materials Center | EBF | Class II | |
| K955150 | Maxi-Flow | Bio-Medical Devices, Inc. | BYY | Class II | |
| K955096 | Capset Calcium Sulfate Bone Graft Plaster | Lifecore Biomedical LLC | LYC | Class II | |
| K955055 | Nulife | Med-Tech Rubber & Engineering Industries | LYY | Class I | |
| K955029 | Powder-Free Lates Exam Gloves with Protein Claim | Shen Wei (USA), Inc. | LYY | Class I | |
| K954984 | Minibore Stopcock Set | Distronic Sterile Products, Inc. | FMG | Class II | |
| K954983 | Extension Set with Check Valve | Distronic Sterile Products, Inc. | FPA | Class II | |
| K954744 | Zch Alpha System | Zimmer GmbH | JDI | Class II | |
| K954455 | Niomed Bouffant Caps | Amerasia Corp. | FYF | Class I | |
| K954454 | Niomed Surgical Hood | Amerasia Corp. | FYF | Class I | |
| K953335 | Micro Therapeutics Variable Infusion Length Catheter | Medtronic, Inc. | FOZ | Class II | |
| K953068 | Oxboro-Medical Foam Instrument Holder | Oxboro Medical Intl., Inc. | KCT | Class II | |
| K952961 | Body Fluid Barrier Kit | Lhb Industries, Inc. | FXX | Class II | |
| K952515 | Coacute Antithrombin R Chromogenic Assay | Chromogenix AB | JBQ | Class II | |
| K940832 | i.v. Administration Set Connecting Device | Sierra Medical Devices | FPA | Class II | |
| K923693 | Klorman | Matrix Medica, Inc. | LRJ | Class I | |
| K955651 | Medtronic Sherpa Guiding Catheter | Medtronics Interventional Vascular | DQY | Class II | |
| K955618 | Bipolar Cutter | Cook Incorporated | GEI | Class II |