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 |
|---|---|---|---|---|---|
| K073498 | Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf System | Rudolf Medical GmbH + Co. KG | GEI | Class II | |
| K082644 | Glidesheath | Terumo Medical Corp. | DYB | Class II | |
| K082569 | Entellus Medical Flexible Endoscope and Eyepiece | Entellus Medical, Inc. | EOB | Class II | |
| K082425 | Tandemheart Transseptal Cannula- Ef 72 | Cardiacassist, Inc. | DWF | Class II | |
| K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: Mc002 | Bionostics, Inc. | JJX | Class I | |
| K082257 | Zeno Ai Eco Disc | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K082245 | Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-Lv | Ceremed, Inc. | KHJ | Class II | |
| K082226 | S40 Creatine Kinase (Ck) | Alfa Wassermann Diagnostic Technologies, Inc. | JHS | Class II | |
| K081574 | Zoll R Series | ZOLL Medical Corporation | LDD | Class II | |
| K081493 | Infiltration Kit | Dmg USA, Inc. | EBC | Class II | |
| K081485 | Somnowatch | Somnomedics AG | MNR | Class II | |
| K081451 | Rightest Blood Glucose Monitoring System, Model Gm100 | Bionime Corporation | NBW | Class II | |
| K082542 | Aneroid Sphygmomanometer with Stethoscope Model Hbpk-a | Cardicare Company, Ltd. | DXQ | Class II | |
| K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | HWC | Class II | |
| K082362 | Surshield Safety i.v. Catheter | Terumo Medical Corp. | FOZ | Class II | |
| K082192 | Infrared Ear Thermometer, Model Et-101A | Sejoy Electronics & Instruments Co., Ltd. | FLL | Class II | |
| K082121 | Easymax Self Monitoring Glucose Test System, Model # Eps08005 | Eps Bio Technology Corp. | CGA | Class II | |
| K082107 | Cliniqa Liquid Qc Urine Chemistry Controls, Levels 1 and 2 | Cliniqa Corporation | JJY | Class I | |
| K081910 | Non-Sterile, Powdered Latex Examination Glove | Siam Sempermed Corp., Ltd. | LYY | Class I | |
| K081810 | Pulpdent Temporary Crown and Bridge Material | Pulpdent Corporation | EBG | Class II | |
| K081792 | Spy Analysis Toolkit, Model Sa9000 | Novadaq Technologies ULC | LLZ | Class II | |
| K081784 | Mastergraft Putty | Medtronic Sofamor Danek | LYC | Class II | |
| K081742 | Baxano Neural Localization Probe 1.75 and 1.25 | Baxano, Inc. | ETN | Class II | |
| K081738 | Ultrasonic Nebulizer System, Model Hl100 | Health & Life Corporation | CAF | Class II | |
| K081705 | Lang Dental Resincap Pattern and Coping Acrylic Resin | Lang Dental Mfg Co, Inc. | EBG | Class II | |
| K081613 | Sparc System / Monarc, Monarc C, Monarc + Systems | American Medical Systems, Inc. | OTN | Class II | |
| K081579 | Inventus Implant System | Inventus Co., Ltd. | DZE | Class II | |
| K081115 | G-Mops G5 Series | Vitrolife Sweden AB | MQL | Class II | |
| K080788 | Vivascope System, Model 1500, 3000 | Lucid, Inc. | PSN | Class II | |
| K080722 | Primado Surgical Drill | Nakanishi Inc. | ERL | Class II | |
| K080638 | Claro | Clrs Technology Corporation | GEX | Class II | |
| K080156 | Osseospeed Tm Profile System | Astra Tech, Inc. | DZE | Class II | |
| K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | GEX | Class II | |
| K082386 | Inreach Planning Laptop | Medtronic, Inc. | LLZ | Class II | |
| K082279 | Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2 | Abbott Medical | OCL | Class II | |
| K082270 | Octane Vertebral Body Replacement (Vbr) System | Vertiflex, Inc. | MAX | Class II | |
| K082023 | Reprocessed Electrophysiology Catheters | Stryker Sustainability Solutions | NLH | Class II | |
| K081117 | G-2 V5 | Vitrolife Sweden AB | MQL | Class II | |
| K081114 | G-1 V5 | Vitrolife Sweden AB | MQL | Class II | |
| K073425 | Modification to Aurora MRI System | Aurora Imaging Technology, Inc. | LNH | Class II | |
| K073019 | Silvermed Antimicrobial Silver Hydrogel | Argentis Biomedical Incorporated | FRO | Unclassified | |
| K071132 | G8 Automated Hplc Analyzer, Model Hlc-723 G8 | Tosoh Bioscience Inc | LCP | Class II | |
| K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | NKB | Class II | |
| K081394 | PTFE Interlock Peelable Introducers | Greatbatch Medical | DYB | Class II | |
| K080216 | Supramesh Extra | S. Jackson, Inc. | FTL | Class II | |
| K082494 | Drad3000e/radrex-I | Toshiba America Medical Systems, In.C | MQB | Class II | |
| K082484 | Accelawave System | Genesis Biosystems Inc. | ONF | Class II | |
| K082483 | Quantra | Hologic, Inc. | LLZ | Class II | |
| K082368 | Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020Tc Spect Imaging System | Digirad Corp. | KPS | Class II | |
| K082342 | Modification to Capstone Spinal System | Medtronic Sofamor Danek | MAX | Class II |