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 |
|---|---|---|---|---|---|
| K922941 | Clinical Neuro Systems Monitorr Icp Ventricular Ca | Clinical Neuro Systems, LLC | JXG | Class II | |
| K922936 | Clinical Neuro Systems Monitorr Icp Lumbar Cathete | Clinical Neuro Systems, LLC | JXG | Class II | |
| K922800 | Platelet Aggregation Reagents | Chrono-Log Corp. | GHR | Class II | |
| K922508 | Rubber Frame Sunglasses | Jedda Dist., Inc. | HQY | Class I | |
| K921954 | Isotron III | Excel Tech., Ltd. | LIH | Class II | |
| K921953 | Multi III | Excel Tech., Ltd. | LIH | Class II | |
| K921826 | Kodak Insight Portable Imaging System | Eastman Kodak Company | IXA | Class II | |
| K921178 | Pti-a, Pti-P, Pti-N Disposable Pneumotachs | Medical Associated Services, Inc. | JAX | Class II | |
| K920762 | Biospsy Forceps | Boston Scientific Corporation | OCZ | Class II | |
| K920470 | Meyer Foreign Body Locator | Seymour W. Meyer | IZH | Class II | |
| K920342 | Bard Stone Removal Balloon Catheter | C.R. Bard Inc | GCA | Class II | |
| K914188 | Koagulab Cts Chromogrnic Testing System | Ortho Diagnostic Systems, Inc. | JPA | Class II | |
| K912837 | Mcafee Spinal System for Posterior Applications | Kirschner Medical Corp. | KWP | Class II | |
| K912364 | Electronic Ultrasound Scanner Eub-315, Modified | Hitachi Medical Corp. of America | ITX | Class II | |
| K923318 | Columnmate Beta-Thal Hba2 Control - Normal | Helena Laboratories, Corp. | JPD | Class II | |
| K923317 | Columnmate Beta Thal Hba2 Control-Abnormal | Helena Laboratories, Corp. | JPD | Class II | |
| K923010 | Magnetic Resonance Diagnostic Device | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K922851 | Cytology Brush | Annex Medical, Inc. | FDX | Class II | |
| K922678 | Loop Retriever | Annex Medical, Inc. | FFL | Class II | |
| K921882 | The Cleaner Accessory | Eaton Medical Corp. | LYL | Class II | |
| K921697 | Flexiflo Companion Enteral Pump Sets and Container | Abbott Medical | KNT | Class II | |
| K921077 | Disposable Intubation Kits | Coast Medical Corp. | BTR | Class II | |
| K913039 | Fllynn(r) Genesis Ac | O-Two Systems Intl., Inc. | BTL | Class II | |
| K923924 | Voicewave | Personal Sound Technologies, Inc. | ESD | Class I | |
| K923314 | Automates Coma Plus Cocaine Metabolite Assay | Serex, Inc. | JXO | Class II | |
| K923039 | Miles Urine Creatinine Method | Kulzer GmbH | CGX | Class II | |
| K923038 | Miles Potassium Method | Kulzer GmbH | CEM | Class II | |
| K922916 | Bard Marlex Mesh Dart | C.R. Bard Inc | FTL | Class II | |
| K922915 | Emit 2000 N-Acetylprocainamide Assay and Calibrat | Syva Co. | LAN | Class II | |
| K922914 | Emit 2000 Procainamide Calibrators | Syva Co. | LAR | Class II | |
| K922913 | Emit 2000 Quindine Assay Quididine Calibrators | Syva Co. | LBZ | Class II | |
| K922720 | Group Auditory Training System | Phonic Ear, Inc. | EPF | Class II | |
| K922554 | Standard Imaging Hdr 1000 Ion Chamber | Standard Imaging Inc. | JAQ | Class II | |
| K922540 | Wound Dressing | Les Laboratorires Brothier, S.A. | KMF | Class I | |
| K922492 | Specialty Packaging Prod Bacterial/viral Filter | Specialty Packaging Producs, Inc. | CAH | Class II | |
| K922477 | Model 105 Ventilator, Modification | Infrasonics Corp. | CBK | Class II | |
| K922411 | Kodak Ektascan, Xlt7720, Xlt7700, Pcd 2000 | Eastman Kodak Company | LMC | Class II | |
| K922353 | Digoxin Coated Tube Ria | Monobind, Inc. | LCS | Class II | |
| K921604 | Touch N' Heat, Modification | Analytic Technology | EKZ | Class II | |
| K920980 | Usci Linx Ez Guide Wire Extension W/pro/pel Coat | C.R. Bard Inc | DQO | Class II | |
| K920850 | Gac Thumb-Sucking Control Appliance | Gac Intl., Inc. | DZC | Class I | |
| K920308 | Cowboy II | KCI USA, Inc. | JOW | Class II | |
| K920227 | Quadrature Shoulder Contour Coil | Magnetic Research, Inc. | LNH | Class II | |
| K915270 | Patient Controlled Syringe Pump Type 3300 | Graseby Medical, Ltd. | MEA | Class II | |
| K912664 | Tec Rotating Dual Hemovalve | Intensive Technology, Inc. | DYB | Class II | |
| K921468 | Permamesh Hydroxylapatite Matrix | Ceramed Corp. | LYC | Class II | |
| K920224 | Doscope and Acessories | Applied Laparoscopy | FBN | Class II | |
| K923070 | Wako Igg-Ha | FUJIFILM Healthcare Americas Corporation | CFN | Class II | |
| K922780 | Antimicrobial Susceptibility Test Panel | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K922765 | Biostars Strep a Oia -- Modification | Biosearch Medical Products, Inc. | GTY | Class I |