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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K854712 | Visible-Herpes Tm Test System | Isolab, Inc. | GQO | Class II | |
| K861685 | Superlon (Unilon) Carboxylate Cement | Carlisle Laboratories, Inc. | EMA | Class II | |
| K861617 | The Partner Spectrophotometer | Pharmacia, Inc. | JJQ | Class I | |
| K861587 | Weck Concentrated Liquid Cleaner | Palmetto Chemical & Supply Co., Inc. | FLG | Class I | |
| K861486 | Spirometry Module | Medical Graphics Corp. | BTY | Class II | |
| K861464 | Lead Body Changes to Hi Perform & Fast-Pass Leads | Pacesetter Systems | DTB | Class III | |
| K861220 | Lunderquist - Ring Ptc Drainage Catheter | Meadox Surgimed, Inc. | FGE | Class II | |
| K860295 | Fetascan 1500 | International Biomedics, Inc. | HGM | Class II | |
| K854920 | Therapy Cassetts | Alpha Therapeutic Corp. | MCU | ||
| K854737 | Surgical Irrigation Device (Sid)/arthroscopic Surg | Orthopaedic Devices, Ltd. | FQH | Class II | |
| K854299 | Gore-Tex Periodontal Material | W. L. Gore & Associates, Inc. | NPK | Class II | |
| K861734 | Regan-Lowe Agar | Gibco Laboratories Life Technologies, Inc. | JSJ | Class I | |
| K861711 | Skin Staple Remover with Sponge Sterile Disposable | Busse Hospital Disposables | GDT | Class I | |
| K861709 | A TENS (Model Ai-86) | American Imex | GZJ | Class II | |
| K861705 | Corona 3000 (Dermatologic Ultraviolet Lamp) | Vita-Tan Corp. | FTC | Class II | |
| K861636 | Miami-Sunny | Sunworld Corp. | FTC | Class II | |
| K861423 | Demand Oxygen Saver System (D02s) | Applied Membrane Technology, Inc. | BZQ | Class II | |
| K861408 | Modified Uniscept Kb Labeling Amendment | Analytab Products, Inc. | JWY | Class II | |
| K861359 | Cardiac Monitor, Cardiotachometer and Alarm | Hewlett-Packard Co. | DPS | Class II | |
| K861268 | Arthroscope W/cannulated Obtur/drill Bits & Wrench | Mizuho Orthopedic Systems Inc | HRX | Class II | |
| K861216 | Protein C Control Plasma | American Bioproducts Co. | GGP | Class II | |
| K861198 | Custom Procedure Kit (Various Sub-Titles) | Quali-Med, Inc. | |||
| K860923 | Ez Detect, 5 Minute Strep-a Color Test | Self Care Systems, Inc. | GTZ | Class I | |
| K860572 | Glycohemoglobin, in-Vitro Diagnostic Reagent Set | Horiba Instruments Incorporated | LCP | Class II | |
| K855045 | Model 535 Neo-Trak Recorder | GE Medical Systems Information Technologies, Inc. | DSF | Class I | |
| K855027 | Pulse Oximeter | Physio Control, Inc. | DQA | Class II | |
| K854434 | Dinamap Vital Signs Monitor Model 8100 | Critikon Company, LLC | DXN | Class II | |
| K861483 | Angiographic Catheter (Cardiology & Radiology) | Mallinckrodt Critical Care | DQO | Class II | |
| K861478 | Bard Double Pigtail Ureteral Stent | C.R. Bard Inc | FAD | Class II | |
| K861469 | Duthoy Stone Basket | Lake Region Mfg., Inc. | FFL | Class II | |
| K860943 | Jimmy John III, Rectal Nozzle (Modification) | Colon Therapeutics | KPL | Class II | |
| K860863 | Endo-Tripton, Mechanical Gallstone Crusher | George Percy Mcgown | LQC | Class II | |
| K860818 | One Time Enteral Feeding Bag | Acme United Corp. | KNT | Class II | |
| K860428 | Sm-Rnp Autoantibody Test System | IMMUNO CONCEPTS, NA, Ltd. | LLL | Class II | |
| K860235 | Mod 426, Medical Ultrasonic Diagnostc Transducer | Hoffrel Instruments, Inc. | ITX | Class II | |
| K854756 | Short Ragweed Allergen Disc | Immuno Nuclear Corp. | DHB | Class II | |
| K861535 | Optical Markers/fixation Ring/cannu & Irriga Cannu | CooperVision, Inc. | HMR | Class I | |
| K861416 | Canon Auto Acuitometer Cv-10 | Canon Medical Components U.S.A., Inc. | HOX | Class I | |
| K861415 | Canon Auto Ref Keratometer Rk-1 | Canon Medical Components U.S.A., Inc. | |||
| K861407 | Neo-Trak 502 Infant Monitor | GE Medical Systems Information Technologies, Inc. | BZQ | Class II | |
| K861745 | Vickers Ergomatic Microsurg Instru Cardiac Set | Keeler Instruments, Inc. | DWS | Class I | |
| K861585 | Ultraclone 01-2300 Cell Line | Earl-Clay Laboratories, Inc. | KIR | Class I | |
| K861570 | Alpha Tan 1000 and Alpha Tan 1200 | Midwest Marketing Service | FTC | Class II | |
| K861452 | Monostar System: Im Latex Test | U.S. Health Resources Corp. | KTN | Class II | |
| K861447 | Alisun -Type 1200, Type 1000/800 and Type 700/900 | Southern Exposure, Inc. | FTC | Class II | |
| K861440 | Leads Utiliz Volun Stand #1 3.2 Mm Uni/biopolar Co | Pacesetter Systems | DTB | Class III | |
| K860990 | Endoscopic Retrograde Cholangiopancreatography | Endovations | FGE | Class II | |
| K860947 | Leeco-Screen, Strep a (Eia) | Leeco Diagnostics, Inc. | GTZ | Class I | |
| K860768 | Directigen Combo Meningitis Test | BD Becton Dickinson Vacutainer Systems Preanalytic | GTZ | Class I | |
| K860575 | Yeast Identification Panel | American Micro Scan | JXB | Class I |