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 |
|---|---|---|---|---|---|
| K010112 | Bipolar Coagulation System | Enable Medical Corp. | GEI | Class II | |
| K010092 | Xltek Evoked Potential Headbox, Model Real Patient Ep-8-Rp (Proposed) | Excel Tech., Ltd. | GWF | Class II | |
| K010063 | Couch for Total Body Radiation | Arplay Medical S.A. | IYE | Class II | |
| K010010 | Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # Ls1200 & Sligaure Generator | Medtronic, Inc. | GEI | Class II | |
| K010005 | Cynosure Photogenica Dl | Cynosure, LLC | GEX | Class II | |
| K002856 | At3c70 Transducer | Sonora Medical Systems | ITX | Class II | |
| K001997 | White Knight Blue, Green Face Mask, (4 Models) | White Knight Healthcare | FXX | Class II | |
| K001893 | White Knight Masks, Blue, Pink, Yellow, White Masks (13 Models) | White Knight Healthcare | FXX | Class II | |
| K994381 | Prospore2 Self-Contained Biological Indicator | Raven Biological Laboratories, Inc. | FRC | Class II | |
| K010721 | Axiom Artis Modular Angiography System | Siemens Medical Corp. | IZI | Class II | |
| K010663 | Powdered Synthetic Vinyl Patient Exam Glove | Tong Ruhn Medical Products Co., Ltd. | LYZ | Class I | |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936 | Sigma Diagnostics, Inc. | JIX | Class II | |
| K010651 | At Home Drug Test, Model 9133 T | Phamatech Inc. | LCM | Unclassified | |
| K010650 | At Home Drug Test, Model 9073 T | Phamatech Inc. | DIO | Class II | |
| K010646 | At Home Drug Test, Model 9083 T | Phamatech Inc. | MVO | Unclassified | |
| K010645 | At Home Drug Test, Model 9063 T | Phamatech Inc. | DKZ | Class II | |
| K010641 | Ge CT-Pet System | GE Healthcare | JAK | Class II | |
| K010538 | Parset Needleless Primary Set for Blunt Cannula, A10003e, Parset Needleless Secondary Set with Blunt Cannula, A14003e | Rd Medical Mfg., Inc. | FPA | Class II | |
| K010097 | Powder-Free Nitrile Examination Gloves with Aloe Vera, Green (Tested for Use with Chemotherapy Drugs) | Shen Wei (USA), Inc. | LZA | Class I | |
| K010028 | Sheer Thin Aromas Red Latex Condom | Eagle Twe, Inc. | HIS | Class II | |
| K003794 | Elisa Test, Serology | Micro Detect, Inc. | LYR | Class I | |
| K003382 | Sarstedt Needle Protector | Sarstedt ApS | FMI | Class II | |
| K002019 | Retrograde Cardioplegia Cannula, Self-Inflating, with Malleable or Guidewire Stylet | Corcym Inc. | DWF | Class II | |
| K001398 | Reaads Igm Anti-Prothrombin Semi-Quantitative Test Kit | Corgenix, Inc. | DHC | Class II | |
| K010828 | Digital Blood Pressure Monitors, Models Tm-2655, Tm-2655P, & Tm-2655Vp | A and D Engineering, Inc. | DXN | Class II | |
| K010707 | Atlantis Sr Plus Coronary Imaging Catheter, Model 35975 | Boston Scientific Corporation | DQO | Class II | |
| K010622 | Pressure Trak, Model 222-B | Suntech Medical Instruments, Inc. | DXN | Class II | |
| K010263 | Remstar Plus CPAP System | Respironics, Inc. | BZD | Class II | |
| K010201 | Bayer Advia Ims System | Bayer Corp. | MMI | Class II | |
| K004051 | Sheer Thin Aromas Yellow Latex Condom | Eagle Twe, Inc. | HIS | Class II | |
| K004040 | Redtech Gipc 2000 | Red-Tech, Inc. | FFX | Class II | |
| K004039 | Cynosure Photogenica Neo-V | Cynosure, LLC | GEX | Class II | |
| K003873 | Mentor Self-Cath Closed System | Mentor | FCM | Class II | |
| K000814 | Finger Pulse Meter | Bhs Intl., Inc. | DQA | Class II | |
| K010616 | Defender Room Air Cleaner, Model Rac-4000A | Hmi Industries, Inc. | FRF | Class II | |
| K010588 | Elecsysca 15-3 II Assay | Roche Diagnostics GmbH | MOI | Class II | |
| K010571 | Adc Qs/ipd Workstation | Agfa Corp. | LLZ | Class II | |
| K010567 | Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless Tray-Generic (Combined with Cathetr | C.R. Bard Inc | MSD | Class II | |
| K004031 | Nt Swift; Ti\tec; Gates Glidden Drills; Dental Power Endodontic Hand Files | Dental Power, Inc. | EKS | Class I | |
| K002901 | Kendall 14.5 Fr Maxid Cuffed Dual Lumen Catheter | Kendall | MSD | Class II | |
| K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400 | Baxa Corp. | LHI | Class II | |
| K010611 | R & D Designation Ap-047 | Jensen Industries, Inc. | EJT | Class II | |
| K010610 | Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 | Boston Scientific Corporation | ODC | Class II | |
| K010568 | Arthrocare Urology Electrosurgery System | ArthroCare Corporation | KNS | Class II | |
| K010414 | R & D Designation Ap-035 | Jensen Industries, Inc. | EJT | Class II | |
| K010356 | Latex Examination Gloves-Powder Free | Enzymic Technologies Sdn Bhd | LYY | Class I | |
| K010347 | Latex Examination Gloves-Powdered, Nonsterile | Enzymic Technologies Sdn Bhd | LYY | Class I | |
| K010240 | Polycarboxylate (Pca) Cement | Rite-Dent Manufacturing Corp. | EMA | Class II | |
| K010176 | Calex Conditioner | Stephen M Koral, Dmd | EJK | Class II | |
| K010160 | Willi Geller Creapearl | Jensen Industries, Inc. | ELM | Class II |