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 |
|---|---|---|---|---|---|
| K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | MK Meditech | MEG | Class II | |
| K043527 | Relieva Sinus Balloon Dilation Catheter | Exploramed Nc1, Inc. | LRC | Class I | |
| K043503 | Visx Customvue Slit Illuminator with Desktop Charger, Model Cv Si-1 | Visx, Incorporated | HJO | Class II | |
| K042506 | Omron Automatic Blood Pressure Monitor, Model Hem-780M | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K042470 | Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure' Condom | Ssl Americas, Inc. | HIS | Class II | |
| K050450 | Synthetic, Powder-Free Vinyl Examination Gloves | Zibo Blue Intco Plastic & Rubber Products Co., Ltd. | LYZ | Class I | |
| K043324 | Aida with Dicom and Hl7 Interface | Karl Storz Endoscopy-America, Inc. | FET | Class II | |
| K041614 | Microlux Dl | Addent, Inc. | EAZ | Class I | |
| K032959 | Cidex Opa Concentrate | Advanced Sterilization Products | MED | Class II | |
| K050701 | Thigh and Foot Positioner, Suprone Plus, Model Rt-6010 | Bionix Development Corp. | IYE | Class II | |
| K050671 | Enseal Vessel Sealing & Hemostasis System | Surgrx, Inc. | GEI | Class II | |
| K050645 | Cordis Amiia .014 Pta Balloon Catheter | Cordis US Corp. | LIT | Class II | |
| K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | GAW | Class II | |
| K050513 | Mda B.30 | bioMerieux, Inc. | JPA | Class II | |
| K050510 | Echoview/shimasonic Diagnostic Ultrasound System, Model Sdu-1100 | Shimadzu Medical Systems | IYN | Class II | |
| K050488 | Turbt-RF Electrodes and Electrosurgical Devices | Prosurg, Inc | FAS | Class II | |
| K050419 | Qms Vancomycin | Seradyn, Inc. | LEH | Class II | |
| K050115 | Blood Hand Pump Administration Set | Cardinal Health, Alaris Products | BRZ | Class II | |
| K043533 | Surgical Design Circumcision Clamp | Surgical Design Inc | HFX | Class II | |
| K050737 | Neothermia En-Bloc Biopsy System | Neothermia Corp. | GEI | Class II | |
| K050730 | Modification to Orthodontic Composite Bracket System | Ultradent Products Inc. | DYW | Class II | |
| K050679 | Cutera Solera Opus Aesthetic Product | Cutera Inc | GEX | Class II | |
| K050639 | Lumenis Versacut Tissue Morcellator System | Lumenis Ltd | GCJ | Class II | |
| K050491 | H & L Full Automatic (Nibp) Blood Pressure Monitor, Models Hl888ka, Hl888lf & Hl888if | Health & Life Corporation | DXN | Class II | |
| K050319 | Mayfield Mr/ct Skull Clamp, Model 4-0-a-1104 | Integra LifeSciences Corporation | HBL | Class II | |
| K050294 | Cook Ireland Sonnet Polypectomy Snare | Cook Ireland Ltd. | FDI | Class II | |
| K050172 | Cardiassist Counter Pulsation System Series 4000/5000 | Cardiomedics, Inc. | DRN | Class II | |
| K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera Inc | GEX | Class II | |
| K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories | Stryker Sustainability Solutions | NLM | Class II | |
| K043515 | Graftsaver | Vescare, Inc. | GBX | Class I | |
| K043467 | Flexible Spinal Needle | Epimed International, Inc. | BSP | Class II | |
| K043418 | Cook Pediatric Flexor Ureteral Access Shealth | Cook Incorporated | FED | Class II | |
| K043363 | Fresenius Liberty Cycler | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | |
| K043352 | Gocanning Gls-700 E-Pulse Analysis Monitor | Gocanning Technology, Ltd. | DXN | Class II | |
| K050710 | Minimaster Ultrasonic Scaler | E.M.S. - Electro Medical Systems SA | ELC | Class II | |
| K050698 | Modification To:zilver 518 Biliary Stent | Cook Inc. | FGE | Class II | |
| K050670 | Sensor Mobile Sm 100 Vitaphone 1001R Remos | Tms Telemedizinische Systeme GmbH | DXH | Class II | |
| K050577 | Atlantis Sr Pro2 Coronary Imaging Catheter, Model 39014 | Boston Scientific Corporation | DQO | Class II | |
| K050467 | Powder Free Butadiene Exam Gloves with Aloe, Green | Shen Wei (USA), Inc. | LZA | Class I | |
| K050249 | Hl168jp | Health & Life Corporation | DXN | Class II | |
| K050221 | Hemosil Silica Clotting Time | Instrumentation Laboratory Co. | GFO | Class II | |
| K050217 | Flower High-Density Mapping Catheter, 4-4-4 Mm Electrode Spacing), (2-6-2 Mm Electrode Spacing) | Biosense Webster Inc | MTD | Class II | |
| K050106 | Novofine Autocover 30G X 8Mm | Novo Nordisk a/S | FMI | Class II | |
| K050040 | Ms-753 Mars Inflate-Read Blood Pressure Monitor | Mars Medical Products | DXN | Class II | |
| K043204 | Sgarlato Labs Painfree Pump and Pain Control Infusion Pump | Sgarlato Laboratories, Inc. | FRN | Class II | |
| K040335 | Mooncup, Style a & B | Mooncup Limited | HHE | Class II | |
| K050667 | R2 Family of Image Display Units with R2 Uniform Display Software | R2 Technology, Inc. | LLZ | Class II | |
| K050563 | Ekos Peripheral Infusion System | Ekos Corp. | QEY | Class II | |
| K050539 | Size 1 Triathlon Posterior Stabilized (Ps) Tibial Insert | Howmedica Osteonics Corp | JWH | Class II |