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 |
|---|---|---|---|---|---|
| K862286 | Arthrophonometer | Arthrotek, Inc. | NFQ | Class I | |
| K861514 | Vna Optical Correlator | Vna Systems, Inc. | LLZ | Class II | |
| K864878 | Icu/cpu Transport Tray | Mizuho Orthopedic Systems Inc | FNJ | Class I | |
| K864856 | Model 5866-24 Pacemaker Lead Adaptor | Medtronic, Inc. | DTB | Class III | |
| K864823 | Behind the Ear Hearing Aids, Bernafon Colibri, C1 | Bernafon LLC | ESD | Class I | |
| K864738 | Model 366-14 Intermedics Lead Connector Cap | Intermedics, Inc. | DTB | Class III | |
| K864682 | Salt Creek P.i. Tray | Salt Creek Medical Technologies | |||
| K864640 | Ancor Pervenous Active Fixation Unipolar Lead | Cordis US Corp. | DTB | Class III | |
| K864637 | Modified Eschmann Dilatation Catheter | Eschmann Bros. & Walsh, Ltd. | |||
| K864601 | Ccs Polysafe(tm) Endocardial Pacing Lead | Cardiac Control Systems, Inc. | DTB | Class III | |
| K864535 | Tracheobronchial Suction Catheter, Cat. No. 6110 | Concord Laboratories, Inc. | BSY | Class I | |
| K864503 | Modified Rlv-2100 B | American Omni Medical, Inc. | DWD | Class II | |
| K864468 | Tracheobronchial Suction Catheter | Sheridan Catheter Corp. | BSY | Class I | |
| K864352 | Modified Peel-Away Introducer Set Line | Quinton, Inc. | DYB | Class II | |
| K864331 | Tri-Lock Long Stem Modular Neck | Depuy, Inc. | |||
| K864330 | Shear Force Gauge | American Edwards Laboratories | DXE | Class II | |
| K864153 | Pace Implant. Lead/tined/atrial/j/model 3290 | Pace Medical | DTB | Class III | |
| K864062 | Pruitt Embolectomy/irrigation Catheter (Modified) | Ideas for Medicine, Inc. | DXE | Class II | |
| K863936 | Duffy Bolus Injector | Viox Corp. | IWR | Class I | |
| K863917 | Cvi 8.5 French Percutaneous Sheath Introducer Sys. | Cardio-Vascular Innovations, Inc. | DYB | Class II | |
| K863916 | Cvi 16 Gauge Central Vein Catherization System | Cardio-Vascular Innovations, Inc. | DQY | Class II | |
| K863914 | Modification to Dynascope Series Monitors | Fukuda Denshi USA, Inc. | DPS | Class II | |
| K863904 | Disposable ECG Monitoring Electrode | Clinical Data, Inc. | DRX | Class II | |
| K863855 | Accusat | Datascope Corp. | DQA | Class II | |
| K863705 | Computer Controlled Extension (Ccx) | Varian Assoc., Inc. | IYE | Class II | |
| K863684 | Uresil Subclavian Catheter | Uresil, LLC | DQY | Class II | |
| K863536 | Medtronic Model 5013 | Medtronic, Inc. | DTB | Class III | |
| K863535 | Life-Trace 18 Single-Trace Cardiac Monitor/record. | Elekta Limited | DPS | Class II | |
| K863369 | Mel-16-1, Mel-16-3 & Mel-16-5 Tdk ECG Electrodes | Tdk Corp. | DRX | Class II | |
| K863153 | Modification of Cardiointegram/cardiointegraph | Ocg Technology, Inc. | DXG | Class II | |
| K862055 | Canwest Ovu-Blue | Canwest Medictex, Inc. | CEP | Class I | |
| K862051 | Model 436-01 Biopore Implantable Pacing Lead | Intermedics, Inc. | DTB | Class III | |
| K861241 | Angiotopo Catheter | Houston Biomedical, Inc. | DQO | Class II | |
| K861188 | Sperm Capacitation Medium | Irvine Scientific LLC | HDR | Class II | |
| K864945 | Tandem(r) M-Pak(tm) Pap Immunoenzymetric Assay | Hybritech, Inc. | JFH | Class II | |
| K864907 | Suntanning Lamp | Interlectric Corp. | FTC | Class II | |
| K864817 | S&w Model High-Low Mat Table, Various Models | S & W Enterprises, Inc. | INQ | Class I | |
| K864755 | Pseudomonas Cepacia Selective Agar, Dri & Pre-Form | Gibco Laboratories Life Technologies, Inc. | JSJ | Class I | |
| K864740 | Bone Marrow Collection Medium | Bioclinical Laboratory Services, Inc. | KIT | Class I | |
| K864733 | Lkb 2260 Macrotome | Lkb Instruments, Inc. | IDO | Class I | |
| K864727 | Cult-Ur | R.P. Laboratories, Inc. | LIO | Class I | |
| K864706 | Raichem(tm) Ammonia Reagent | Reagents Applications, Inc. | JIF | Class I | |
| K864674 | Microdilution Identification Panels | American Micro Scan | JSE | Class I | |
| K864669 | Am Cath Eswl Stent | Inter-Med, Inc. | FAD | Class II | |
| K864646 | Sorvall Capspin Microhematocrit Centrifuge | E.I. Dupont de Nemours & Co., Inc. | GKF | Class II | |
| K864497 | Coagulation Extrinsic Deficient Plasmas | Instrumentation Laboratory Co. | GGP | Class II | |
| K864481 | Coagulation Intrinsic Deficient Plasmas | Instrumentation Laboratory Co. | GGP | Class II | |
| K864392 | Protime Automate Test Kit | American Bioproducts Co. | GJS | Class II | |
| K864333 | Digoxin Fpia Fluorescence Polarization Immunoassay | Windsor Laboratories, Inc. | KXT | Class II | |
| K864224 | Abbott Spectrum Glucose Reagent | Abbott Medical | CGA | Class II |