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 |
|---|---|---|---|---|---|
| K954929 | Charisma Single Dose | Kulzer GmbH | EBF | Class II | |
| K954886 | Model Nos. 7495 and 501826 Extensions | Medtronic, Inc. | GZB | Class II | |
| K954845 | Expandacell Injecto-Pak Nasal Pack | Summit Medical, LLC | EMX | Class I | |
| K954745 | Mill-Rose Rigid Scope Cleaning Brushes | Mill-Rose Laboratory | FEB | Class II | |
| K954626 | Cedia Dau Benzodiazepine Assay(modification) | Microgenics Corporation | JXM | Class II | |
| K954599 | Conmed Trogard Electronic Trocar System | Conmedcorp | GEA | Class I | |
| K954256 | Anti-Tpo | Biomerica | JNL | Class II | |
| K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | DYB | Class II | |
| K953963 | Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial Intubation | Rusch, Inc. | BTS | Class II | |
| K953797 | Sharps Disposal Containers | Bemis Mfg. Co. | MMK | Class II | |
| K952746 | Alkaline Phosphatase Reagent System | Medical Diagnostic Technologies, Inc. | CJE | Class II | |
| K951566 | Swan-Ganze Continuous Cardiac Output/oximetry/venous Infusion Port/ejection Fraction/volumetric (Cco/svo2/vip/ref) Cath] | Baxter Healthcare Corporation | DYG | Class II | |
| K945944 | Nihon Kohden Wep-8430A Central Telemetry System | Nihon Kohden America Inc | DSI | Class II | |
| K954782 | Kowa Portable Slit Lamp Sl-14 & Sl-14B | Kowa Pharmaceuticals America, Inc. | HJO | Class II | |
| K954778 | Cholestech Ldx System | Cholestech Corp. | LBS | Class I | |
| K954666 | Mph50, Mph65, and Mph80 | GE Healthcare | IZO | Class I | |
| K954289 | Synthes Cannulated Angle Blade Plate | Synthes (USA) Products LLC | KTW | Class II | |
| K954167 | Humphrey Field Analyzer (Hfa II) | Carl Zeiss, Inc. | HPT | Class I | |
| K954139 | Aquasoft (Tetrafilcon a) Daily Wear Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | LPL | Class II | |
| K954039 | Gyrex Privilege | Elscint, Inc. | LNH | Class II | |
| K953876 | Pentax Ultrasound Endoscope Model Fg-32Ua (Modification) | Pentax Precision Instrument Corp. | ODG | Class II | |
| K953766 | Kendall Safetap Spinal Anesthesia Tray | Kendall Healthcare Products Co. Div.Of Tyco Health | CAZ | Class II | |
| K953259 | Voxelview | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K953198 | Corticellous Bone Screw | Hayes Medical, Inc. | HWC | Class II | |
| K952684 | Vertex Epic Mcd | Philips North America LLC | KPS | Class II | |
| K952485 | Lasernet Image Manager/print Server | Frantz Imaging, Inc. | LMA | Class II | |
| K942604 | Signa Advantage Sp Magnetic Resonance System | GE Healthcare | LNH | Class II | |
| K954748 | Pocketalker Pro | Williams Sound, LLC | LZI | Class II | |
| K954707 | Bronchoscope | FUJIFILM Healthcare Americas Corporation | EOQ | Class II | |
| K954668 | Hp Echo Image Management System | Hewlett-Packard Co. | LLZ | Class II | |
| K954099 | Select Iui | Select Medical Systems, Inc. | MFD | Class II | |
| K954090 | Auto Suture* Sterilization Tray** | United States Surgical, A Division of Tyco Healthc | KCT | Class II | |
| K954050 | Resectoscopes | Karl Storz Endoscopy-America, Inc. | FJL | Class II | |
| K954023 | Osteonics Secur-Fit Ha Psl Extra Acetabular Component System | Osteonics Corp. | MEH | Class II | |
| K954007 | Parallel | Johnson & Johnson Consumer Products, Inc. | KGX | Class I | |
| K953852 | Model Ipd Oxygen Conserving Device | Invacare GmbH | NFB | Class II | |
| K953817 | Aristo Medical Model 2101 Patient Monitor | Aristo Medical Products, Inc. | DQA | Class II | |
| K953801 | Varicam | Elscint, Inc. | KPS | Class II | |
| K953771 | Operating Laryngoscopes & Accessories Forceps, Protectors | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K953768 | Cordis Webster A20 Diagnostic Deflectable Tip Catheter | Cordis Webster, Inc. | DRF | Class II | |
| K953761 | Axsym Tricyclic Antidepressants | Abbott Medical | LFH | Class II | |
| K953617 | Resposable Resuscitator | Medical Marketing Concepts | BTM | Class II | |
| K953292 | Cp 100/30 | Micro-Focus Imaging., Inc. | IZL | Class II | |
| K953227 | Casper | Northwest Medical Physics Center | IXI | Class II | |
| K952913 | Applicators for Varian Varisource Remote High Soes Rate Afterloader | Varian Assoc., Inc. | JAQ | Class II | |
| K952719 | Biocircuits Ios (in-Office System) | Biocircuits Corp. | KHO | Class I | |
| K952612 | Durasil | The S. F. Group, Inc. | MDA | Class I | |
| K952564 | Inspect/prospect | Philips North America LLC | KPS | Class II | |
| K952465 | Probe Personal Lubricant - Silky Light | Davryan Laboratories, Inc. | HIS | Class II | |
| K952464 | Probe Personal Lubricant - Classic | Davryan Laboratories, Inc. | HIS | Class II |