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 |
|---|---|---|---|---|---|
| K911787 | Monopolar Sphinctertome | Everest Medical Corp. | GEI | Class II | |
| K905802 | Centauri/pegasus | Pfizer Laser Systems | GEX | Class II | |
| K912762 | K-Cap-I, Sterile | Westcon Orthopedics, Inc. | LYT | Class II | |
| K912536 | Calcitonin Kit Mitsubishi Yuka | Mitsubishi Yuka America, Inc. | JKR | Class II | |
| K912251 | King Diagnostics Glucose (Hk) Reagent Strip Test | King Diagnostics, Inc. | CFR | Class II | |
| K911906 | Magnetic Hdl Cholesterol Test | Reference Diagnostics, Inc. | LBR | Class I | |
| K911549 | Injector Fill Tube | The R Group | DXT | Class II | |
| K911382 | Ipi Algo-Line Catheter | Pudenz-Schulte Medical Research Corp. | MAJ | Class II | |
| K910001 | Model 8604-Fo Pulse Oximeter | Nonin Medical, Inc | DQA | Class II | |
| K904966 | Datamed Model 401A Transreciever | Datamed, Inc. | DXH | Class II | |
| K903512 | Futurecare Carelynk IV System | Futurecare Systems, Inc. | DRT | Class II | |
| K912967 | Bivona Aire-Cuf Tracheostomy Tube W/talk Attach. | Bivona Medical Technologies | JOH | Class II | |
| K912786 | W-H Topair Dental Handpiece | Sabra-The Dental Products Group | EFB | Class I | |
| K912766 | Amerlite Ck-Mb Assay | Amersham Corp. | JHY | Class II | |
| K912648 | Ise/na+ | Boehringer Mannheim Corp. | JGS | Class II | |
| K912647 | Ise/ci- | Boehringer Mannheim Corp. | CGZ | Class II | |
| K912569 | Synermed Phosphorus Reagent Kit | Synermed, Inc. | CEO | Class I | |
| K912560 | Nova 12 Analyzer | Nova Biomedical Corporation | JGS | Class II | |
| K912441 | Linearity Test Kits | Boehringer Mannheim Corp. | JJY | Class I | |
| K912440 | Ultra Blood Glucose Monitoring System | Home Diagnostics, Inc. | CGA | Class II | |
| K912438 | Models 5,8,20,20S Argon Ion Lasers | Hgm Medical Laser Systems, Inc. | GEX | Class II | |
| K912386 | Rep Spe Plus (Ponceau S) System, 3163, 3164 & 3165 | Helena Laboratories, Corp. | CEF | Class I | |
| K912181 | E-Z Lift Crank Imaging Table | Med-Tron Products, Inc. | IYZ | Class I | |
| K912150 | Beckman Anti-Streptolysin O (Aso) Kit | Beckman Instruments, Inc. | GTQ | Class I | |
| K912135 | Xy Imaging Table | Med-Tron Products, Inc. | IYZ | Class I | |
| K912133 | Px Coulter(r) Cell Control | Coulter Electronics, Inc. | JPK | Class II | |
| K911997 | Tenderfoot(r), Modification | Accriva Diagnostics, Inc. | FMK | Class II | |
| K911996 | Surgicutt-Bleeding Time Device, Modification | Accriva Diagnostics, Inc. | JCA | Class II | |
| K911995 | Prothrombin Time (Pt) by Hemochron, Modification | Accriva Diagnostics, Inc. | GJS | Class II | |
| K911994 | Hemochron(r) Aptt, Modification | Accriva Diagnostics, Inc. | GFO | Class II | |
| K911918 | Swivel Horseshoe Headrest | Cerenovus, Inc. | HBM | Class I | |
| K911917 | Codman Pediatric Horseshoe Headrest | Cerenovus, Inc. | HBM | Class I | |
| K911866 | Trace Total/direct Bilirubin Reagent | Trace Scientific, Ltd. | CIG | Class II | |
| K911754 | Scissors,graspers,forceps | American Cynamid Co. | GCJ | Class II | |
| K911682 | Airstrip First Aid & Post-Op Dressing | Smith & Nephew United, Inc. | KGX | Class I | |
| K911624 | Vision Bg Test Strip | British-American Medical, Inc. | CGA | Class II | |
| K911501 | Shimadzu Whole Body X-Ray CT Scanner Sct-5000Tx | Shimadzu Medical Systems | JAK | Class II | |
| K911500 | Shimadzu Whole Body X-Ray CT Scanner Sct-5000Th | Shimadzu Medical Systems | JAK | Class II | |
| K911459 | Granulyte Powder Dialysate Concentrate and Mixing | Fresenius USA, Inc. | KPO | Class II | |
| K911418 | Gum Massager | Burn-Henderson Partnership | JET | Class I | |
| K911301 | Vzv Igm Test | Gull Laboratories, Inc. | GQX | Class II | |
| K911278 | Olympus Af Angioscope System | Olympus Corp. | LYK | Class II | |
| K911240 | Hepcon Hms with Body Surface Area Calculation | Hemotech, Inc. | JOX | Class II | |
| K911214 | Nutip (Tm) Syringe Shield | Western M/D, Inc. | EKJ | Class I | |
| K910808 | Q-Smart Holter Systems | Quinton, Inc. | DSI | Class II | |
| K910144 | 12-Lead ECG Adaptor for Use W/lifepak 10 Defib/mon | Physio Control, Inc. | LDD | Class II | |
| K905274 | Vitalmax 2100/2200 | Pace Tech, Inc. | DRT | Class II | |
| K904448 | Townley Total Knee (Ttk) | Biopro, Inc. | JWH | Class II | |
| K903660 | Dermalight Psoracomb | Solitec GmbH | IOB | Class II | |
| K903237 | Cardiocap Cmx-104 Monitor | Datex Division Instrumentarium Corp. | DXN | Class II |