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 |
|---|---|---|---|---|---|
| K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products Fs | Ortho-Clinical Diagnostics, Inc. | NQD | Class II | |
| K041720 | Vitros Chemistry Products Dldl Reagent, Calibrator Kit 19, Fs Calibrator 1 and Performance Verifiers I and II | Ortho-Clinical Diagnostics, Inc. | MRR | Class I | |
| K041616 | Bgran Synthetic Osteoconductive Scaffoid | Orthos (Uk) Limited | MQV | Class II | |
| K041613 | Novabone - Ar - Resorbable Bone Graft Substitute | Novabone Products, LLC | MQV | Class II | |
| K041573 | Nanma Vacuum Pump Proxzek Model 2M9498s | Nanma Mfg Co., Ltd. | LKY | Class II | |
| K041456 | Snap-Off Screws | Fournitures Hospitalieres Industrie | HWC | Class II | |
| K041451 | Ascension Pyrohemisphere, Models Phs-440-10, Phs-440-20, Phs-440-30, Phs-440-40, Phs-440-50 | Ascension Orthopedics, Inc. | KYI | Class II | |
| K040734 | Modification to Restoration Modular System | Howmedica Osteonics Corp | LZO | Class II | |
| K040191 | Bicontact Hip Stem and Femoral Head | Aesculap Inc | LPH | Class II | |
| K033122 | 5000Z System (OTC) | Prizm Medical, Inc. | NUH | Class II | |
| K042138 | Full Auto Wrist Digital Blood Pressure Monitor Model# Se-311 | Sein Electronics Co., Ltd. | DXN | Class II | |
| K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum A+3 Infusion System with Hospira Mednet Software | Abbott Medical | FRN | Class II | |
| K041974 | Med2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer | Med2000 S.r.l. | BTI | Class II | |
| K041845 | Nexus Pav Luer Lock Device, Model Nis-4 | Nexus Medical, LLC | FPA | Class II | |
| K041843 | Pencil Point Needle | Epimed International, Inc. | BSP | Class II | |
| K041458 | Mare Dental Operative Unit | Denimed Electronica S.H. | EIA | Class I | |
| K041400 | Fortifier Digital Wrist Blood Pressure Monitor, Model Lf-01 | Fortifier International Co., Ltd. | DXN | Class II | |
| K041169 | Piesometer, Model Mk-1 | Canamet Canadian Natl Medical Technologies, Inc. | DXN | Class II | |
| K033738 | Monitoring System, Model Argus Pb-2200 | Schiller, AG | DSK | Class II | |
| K032291 | Tosca Pco2, Spo2 and Pulse Rate Monitoring System | Linde Medical Sensors AG | DOA | Class II | |
| DEN040002 | Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model Ms-8970 | Revvity Health Sciences, Inc. | NQL | Class II | |
| K042204 | Modification to Protege Gps Self-Expanding Nitinol Stent | Medtronic, Inc. | FGE | Class II | |
| K042036 | Airguard Valved Introducer | C.R. Bard Inc | DYB | Class II | |
| K041976 | Smith & Nephew Graft Delivery System | Smith & Nephew, Inc. | FMF | Class II | |
| K041371 | Butler Nucare Prophylaxis Paste with Novamin | Novamin Technology, Inc. | EJR | Class I | |
| K040368 | Vectorvision Hip 3.0 | Brainlab, Inc. | HAW | Class II | |
| K032949 | Spot Check Pulse Oximeter,512/513 | Respironics Novametrix, LLC. | DQA | Class II | |
| K041981 | Guidant Vasoview 6 Harvesting Cannula, Model Vh-2000; Guidant Vasoview 6 Accessory Pack, Model Vh-2004 | Boston Scientific Corporation | GEI | Class II | |
| K041945 | Powder-Free Blue Vinyl Exam Gloves | Glormed Intl., Inc. | LYZ | Class I | |
| K041876 | Nobeldirect Od Implant | Nobel Biocare Uas, Inc. | DZE | Class II | |
| K041848 | Polymer Coat Powder Free Nitrile Examination Gloves, Green and White Color | Pt. Smartglove Indonesia | LZA | Class I | |
| K041840 | Medx Nuquest - Intecam Spect 37-75 System | Medx, Inc. | KPS | Class II | |
| K041436 | Synthetic Surgical Glove-Powderfree Nuzone X2 | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K041409 | Micro-Recording and Stimulation Electrodes-Micro Macroelectrode Model No. 230700-230799 | inomed Inc. | GZL | Class II | |
| K041359 | Body Clock Stimplus and Stimplus Pro | Body Clock Health Care Ltd | GZJ | Class II | |
| K041276 | Powder-Free Nitrile Examination Gloves | Shanghai Motex Healthcare Co., Ltd. | LZA | Class I | |
| K041003 | Immunocard Toxins a & B, Model 712050 | Meridian Bioscience Inc | LLH | Class I | |
| K040996 | Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System | Gyrus Ent LLC | NIX | Class II | |
| K031813 | Ossatura Dental | Isotis NV | LYC | Class II | |
| K042098 | Senorx Introducer | Senorx, Inc. | GEI | Class II | |
| K042080 | Trackease Smart System Blood Glucose System | Home Diagnostics, Inc. | JJX | Class I | |
| K041995 | Modification to: Gp General Purpose Drainage Catheter, Mini-Pig Drainage Catheter, Nephrostomy Catheter, Biliary | Uresil, LLC | GBO | Class I | |
| K041889 | Tri-Ostetic | Berkeley Advanced Biomaterials | MQV | Class II | |
| K041887 | Synthes (USA) 1.0/1.22 Mm Craniofacial Screws | Synthes (USA) Products LLC | DZL | Class II | |
| K041668 | Olympus Crp Latex Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | NQD | Class II | |
| K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | FJL | Class II | |
| K041527 | Aarhus Anchorage System | Medicon, E.G. | DZE | Class II | |
| K041493 | Cementek | Teknimed SAS | MQV | Class II | |
| K041433 | Bright Gold Xh | Ivoclar Vivadent, Inc. | EJS | Class II | |
| K040741 | Ultrasound Localization System Uls 0142 | Hmt High Medical Technologies AG | LNS | Class II |