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 |
|---|---|---|---|---|---|
| K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | Moldex/Metric, Inc. | MSH | Class II | |
| K051126 | Cardioscope Sonoplus 3000 | Pulsonic Ag, Medical Technology | DPS | Class II | |
| K051079 | Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism Lockbox-7 Therapy | Hospicare, Inc. | MRZ | Class II | |
| K051000 | Fortitude Vue Vertebral Body Replacement Device | Spinal Concepts, Inc. | MQP | Class II | |
| K050907 | Fujinon G5 Bronchoscopes, Models Eb-470S, Eb-250S, and Eb-270P | FUJIFILM Healthcare Americas Corporation | EOQ | Class II | |
| K050884 | Adapter Cable | Remington Medical | DTA | Class II | |
| K050731 | Seer Light Extend Compact Digital Holter System | GE Medical Systems Information Technologies, Inc. | MWJ | Class II | |
| K050705 | Tiunite Implants | Nobel Biocare AB | DZE | Class II | |
| K050528 | Powder Free Nitrile Examination Gloves (Blue,white,violet,pink,green,black) | Spi Gloves Sdn. Bhd. | LZA | Class I | |
| K050246 | Sis Dermal Augmentation Strand | Cook Biotech, Inc. | FTM | Class II | |
| K043489 | Enpath Deflectable Catheter | Enpath Medical Incorporated | DQY | Class II | |
| DEN050002 | Lba Afp-L3, Afp-L3 Calibrator Set, Afp-L3 Control Set and Libasys | FUJIFILM Healthcare Americas Corporation | NSF | Class II | |
| K051153 | Powder Free Vinyl Patient Examination Gloves, White (Non-Colored) | Hebei Manful Import & Export Co., Ltd. | LYZ | Class I | |
| K050957 | Eutrochar | Special Devices, Inc. | MDM | Class I | |
| K050948 | Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb Incorporated | LPL | Class II | |
| K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator | Conmed Linvatec | JOS | Class II | |
| K050922 | Ans Scs Accessory Kit | Abbott Medical | GZB | Class II | |
| K050754 | Precimed Cannulated Screw System | Precimed, Inc. | HWC | Class II | |
| K050753 | Stryker Discmonitor | Stryker Corp. | FMF | Class II | |
| K050608 | Synthes Carniofacial Plate and Screw System | Synthes (USA) Products LLC | JEY | Class II | |
| K050168 | Langston Dual Lumen Pressure Monitoring Catheter | Vascular Solutions LLC | DQO | Class II | |
| K043542 | Biopro Tara Femoral Resurfacing Component | Biopro, Inc. | KXA | Class II | |
| K051096 | Apeel Cs Plus Catheter Delivery System, Models 407579, 407580, 407581, 407582 | Abbott Medical | DYB | Class II | |
| K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K050981 | Cd Horizon Spinal System | Medtronic Sofamor Danek USA Inc | MNI | Class II | |
| K050973 | Modification to: Voyager Linux | Mako Surgical Corp. | HAW | Class II | |
| K050702 | Neurosystems 1Tm Monitor | Neurosystems, LLC | GWM | Class II | |
| K050519 | Advanced Turbo Drive System | Linvatec Corporation | GEY | Class I | |
| K050499 | Probloc, Hn Series and Prolong, Pl Series | Life-Tech, Inc. | BSP | Class II | |
| K050322 | Microtek Equipment Drapes | Microtek Medical LLC | KKX | Class II | |
| K050179 | Randox Benzodiazepine Class Assay | Randox Laboratories, Limited | JXM | Class II | |
| K050129 | Celleration Mist Therapy System 5.1 | Celleration, Inc. | NRB | Class II | |
| K050105 | Nexgen Complete Knee Solution Distal Femoral Spacers | Zimmer GmbH | JDI | Class II | |
| K050058 | Theken Reveal Vbr System | Theken Surgical,Llc | MQP | Class II | |
| K042912 | Interx5000 | InterX Technologies | GZJ | Class II | |
| K042729 | Dermacyn Wound Irrigation | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K042543 | Iplan! Digital Templating | Brainlab, Inc. | HAW | Class II | |
| K041059 | Epi-Max | Dermagenics, Inc. | FRO | Unclassified | |
| K051158 | Encor 7 Gauge | Senorx, Inc. | KNW | Class II | |
| K050983 | Irma Trupoint Creatinine Control Kit | Accriva Diagnostics, Inc. | JJX | Class I | |
| K050900 | Mediostar Xt | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K050741 | Ind One Step Hcg Pregnancy Test - Cassette Format | Ind Diagnostic, Inc. | JHI | Class II | |
| K050650 | Novacyte Microendoscope and Accessories, Models Nc1000;ncam1000 | Cytyc Surgical Products | GCJ | Class II | |
| K050418 | Tissue Fixation System | Tfs Manufacturing Pty, Ltd. | FTL | Class II | |
| K050315 | Delta Humeral Cups | Depuy Orthopaedics Inc. | PHX | Class II | |
| K050051 | Armand Endoscope Holder | KLS-Martin L.P. | GCJ | Class II | |
| K043484 | Lanx Spinal Fixation System | Lanx, LLC | MNI | Class II | |
| K043330 | Polypropilene Surgical Sutures | Demetech Corp. | GAW | Class II | |
| K043191 | Repol Angimesh, Angimesh Pre, Folded Mesh, Repol Plug Basic, Repol Plug Cap, Repol Plug Flower and Wings Mesh | Angiologica B. M. SRL | FTL | Class II | |
| K042610 | Dr. Theiss Alergol Pollen Blocker Cream | Dr. Theiss Naturwaren GmbH | NUP | Class II |