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 |
|---|---|---|---|---|---|
| K091730 | Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay | Becton Dickinson & Co | LSL | Class II | |
| K091724 | Bd Probetec Chlamydia Trachomatis (CT) Q Amplified DNA Assay | Becton Dickinson & Co | MKZ | Class I | |
| K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | HWC | Class II | |
| K091176 | Philips Telemedicine Server/system, Model 861441 | Philips North America LLC | MSX | Class II | |
| K091061 | Implicitguide Surgical Suture System | Implicitcare, LLC | GAT | Class II | |
| K090730 | Akita Jet | Activaero America, Inc. | CAF | Class II | |
| K090532 | T.e.a.r. Tech3 | Vision Quest Industries, Inc. | IPF | Class II | |
| K093410 | Autosuture Endo Gia Single Use Black Reload with Tri-Staple Technology | Surgical Devices, A Divsion of Tyco Healthcare | GDW | Class II | |
| K093408 | V-Loc 180 Absorbable Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | GAM | Class II | |
| K093402 | Autosuture Eea Orvil | Surgical Devices, A Global Business Unit Tyco | GDW | Class II | |
| K093253 | Amid Stapler | Safestitch, LLC | GDW | Class II | |
| K093169 | Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown (Sterile) (Non Sterile) | A Plus International, Inc | FYA | Class II | |
| K092826 | Asap Antimicrobial Silver Wound Dressing Gel | American Biotech Labs | FRO | Unclassified | |
| K092597 | Centros Chronic Hemodialysis Catheter Set | Ash Access Technology, Inc. | MSD | Class II | |
| K092501 | Light-Activated Low-Stress Thiol-Ene Composite Restorative Material | Novocol, Inc. | EBF | Class II | |
| K092246 | Nipro Needleless Transfer Device, Models: M285503 and M285505 | Nipro Medical Corporation | LHI | Class II | |
| K091752 | Viztek Wl | Viztek, LLC | KPR | Class II | |
| K093236 | Ethicon Endo-Surgeryoptical Dilator | Ethicon Endo-Surgery Inc | KNQ | Class II | |
| K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe Fo1blu, Foipnk, F14105us | C.R. Bard Inc | KNW | Class II | |
| K092997 | Ultrasonic Tabletop Doppler, Models Sd5 and Sd6 | Edan Instruments, Inc. | KNG | Class II | |
| K092899 | Oper Series Open Type Permanent-Magnet MRI System, Model: Oper-0.3, -0.35, -0.4 | Ningbo Xingaoyi Magnetism Co., Ltd. | LNH | Class II | |
| K092888 | Elecsys Toxo Igg Calcheck 5 | Roche Diagnostics GmbH | JJX | Class I | |
| K092858 | Safersonic Sonography Cover | Safersonic Medizinprodukte GmbH | ITX | Class II | |
| K092741 | Color Lcd Monitor, Model Radiforce Mx241w | Eizo Nanao Corporation | LLZ | Class II | |
| K092487 | Haloflex Energy Generator, Models 1190A-115A and 1190A-230A | Barrx Medical, Incorporated | GEI | Class II | |
| K092434 | Sterngold 2.2Mm Angles Micro Era Dental Implant System | Sterngold | DZE | Class II | |
| K091272 | Besmed Jet Nebulizer Bottle Set | Besmed Health Business Corporation | CAF | Class II | |
| K090739 | Bard Sacrocolpopexy Graft | C.R. Bard Inc | OTO | Class II | |
| K093224 | Densicheck Plus | bioMerieux, Inc. | LON | Class II | |
| K092735 | Greenlight Xps Laser System | American Medical Systems, Inc. | GEX | Class II | |
| K092464 | Spineology Facet Screw | Spineology, Inc. | MRW | Unclassified | |
| K091725 | Perfix Spinal System, Model Sna4530-9610, Snm4530-9610, Sn3020 (Total: 549) | CG MedTech Co., Ltd. | MNH | Class II | |
| K093307 | Asept Pleural Drainage System | PFM Medical GmbH | DWM | Class II | |
| K093301 | Turbohawk Peripheral Plaque Excision System | Medtronic, Inc. | MCW | Class II | |
| K093184 | Envoy Guiding Catheters | Cerenovus, Inc. | DQY | Class II | |
| K092954 | Cadstream Version 5 | Confirma, Inc. | LLZ | Class II | |
| K092669 | Dx-D Imaging Package | AGFA Healthcare Corp. | MQB | Class II | |
| K092640 | Caspian Spinal System | K2M, Inc | MNI | Class II | |
| K092400 | Endogastric Solutions Esophyx2 System with Serosafuse Fastener and Accessories, Model 2.7.5 | Endogastric Solutions, Inc. | ODE | Class II | |
| K092009 | Modification to: Leveen Superslim Needle Electrodes, Models M001262260, M001262270, M001262280, M001262290 | Boston Scientific Corporation | GEI | Class II | |
| K091963 | Vigilant EEG Monitor, Vigilant 2.0 | Infinite Biomedical Technologies, LLC | OLT | Class II | |
| K091914 | Omnis Health Embrace Glucose Control Solution | Bionostics, Inc. | JJX | Class I | |
| K091241 | Masimo Rainbow Set Radical 7 Pulse Co-Oximeter; Rad 87 Pulse Co-Oximeter | Masimo Corporation | DQA | Class II | |
| K090605 | Clampfix | Synthes (USA) Products LLC | NKB | Class II | |
| K090578 | Shimadzu Collimator R-30H | Shimadzu Corp. | IZW | Class II | |
| K093296 | Alexis Laparoscopic System | Applied Medical Resources Corp | KGW | Class II | |
| K093187 | Modification to Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | FDF | Class II | |
| K093160 | Headway 21 Microcatheter, Model: Mc212150s | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K092504 | Surgiquest Airseal Optical Trocar and Cannula System | Surgiquest, Inc. | GCJ | Class II | |
| K092463 | Sorin B-Care5 for the Stockert S5 System | LivaNova Deutschland GmbH | DTQ | Class II |