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 |
|---|---|---|---|---|---|
| K093501 | Elance Vital Signs Monitor and Elance Central Station | GE Healthcare | MHX | Class II | |
| K093366 | Nmi Picc II | Boston Scientific Corporation | LJS | Class II | |
| K093352 | Hg III Fixture System | Hiossen, Inc. | DZE | Class II | |
| K093309 | Pro-Line CT (Basic Tray) Model Mr28036101 | Medcomp ( Medical Components) | LJS | Class II | |
| K093100 | Revlon Rvsp3501 Spa Moisturestay Paraffin Bath (Type Spb3752ea) | Shenzhen Comfort Technology Co., Ltd. | IMC | Class II | |
| K092999 | Nbp Cuff | Draeger Medical AG & Co. KG | DXQ | Class II | |
| K092773 | Cemex Genta, Genta System and Genta System Fast | Tecres SpA | LOD | Class II | |
| K092761 | Proplate, Models 9641C, 9641F, P9641c, P9641f, 9642C, 9642F and P9642c | Bio Protech, Inc. | GEI | Class II | |
| K092685 | Pneumotherml, Model: 5800 | Salter Labs | BZQ | Class II | |
| K092656 | Lanx Posterior Cervicothoracic Spinal Fixation System | Lanx, Inc. | KWP | Class II | |
| K092231 | Gebdi Tribos 501 | Gebdi Dental Products GmbH | ELM | Class II | |
| K092104 | Assure Platinum Blood Glucose Monitoring System | Arkray Factory USA, Inc. | CGA | Class II | |
| K091965 | Powder Free Nitrile Examination Gloves Black; Blue, Grape Scented | Platinum Glove Industries Sdn. Bhd. | LZA | Class I | |
| K091650 | Axs-590 Series | Swr International, Ltd. | CAW | Class II | |
| K091003 | Zimmer Mmc Cup | Zimmer GmbH | KWA | Class III | |
| K090584 | Intrabeam System with Balloon Applicator and Cbg Sets | Carl Zeiss Surgical GmbH | JAD | Class II | |
| K083123 | Medart Model 610 CO2 Laser System & Accessories | MEDART ApS | GEX | Class II | |
| K093499 | Hairmax Lasercomb | Lexington International, LLC | OAP | Class II | |
| K092687 | Venti.plus Hyperinflation Bag System with Pressure Manometer | A Plus Medical | NHK | Class II | |
| K092166 | S. Aureus/cns Pna Fish, Model Kt005 | Advandx, Inc. | NXX | Class I | |
| K092135 | Modification to Ivent 101 | Versamed Medical Systems, Inc. | CBK | Class II | |
| K090925 | Multiple (Apex Locator), Model Rcm-7 | J. Morita USA, Inc. | LQY | Unclassified | |
| K083770 | Coloplast Peristeen Anal Irrigation (Pai) System | MEDLINE INDUSTRIES, LP - Northfield | KNT | Class II | |
| K093512 | Encor Breast Biopsy System | Senorx, Inc. | KNW | Class II | |
| K093488 | Aloka Prosound Alpha 6 Diagnostic Ultrasound System | Aloka Co., Ltd. | IYO | Class II | |
| K093462 | Sonix Ultrasound Scanner | Ultrasonix Medical Corporation | ITX | Class II | |
| K093451 | Omniguide Beampath CO2 Mark III Waveguide Fiber with Low Profile/low Loss Tip | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K093303 | Scoutpro 7F Long Catheters | BIOTRONIK AG | DQY | Class II | |
| K092993 | Advia Centaur Cyclosporine Master Curve Material | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K092868 | Cellavision Dm1200 Automated Hematology Analyzer, Model Xu-10127 | Cellavision AB | JOY | Class II | |
| K092730 | Cosmedent Brushable Composite | Cosmedent, Inc. | EBF | Class II | |
| K092702 | Micrus Microcatheter, Model Courier 270 | Micrus Endovascular Corporation | DQO | Class II | |
| K092607 | Ajust Adjustable Single Incision Sling | C.R. Bard Inc | PAH | Class II | |
| K092591 | Orthopantomograph Op30 | Palodex Group Oy | MUH | Class II | |
| K092522 | Acu007s | Oncology Systems, Inc. | KXK | Class II | |
| K092499 | Laglove Brand Colored Latex Examination Gloves Powdered, Non-Sterile (Pink/green/violet) | La Glove (M) Sdn. Bhd. | LYY | Class I | |
| K092498 | Laglove Brand Nitrile Examination Gloves Powdered, Non Sterile (Pink Color) | La Glove (M) Sdn. Bhd. | LZA | Class I | |
| K092178 | Axsos Stryker Locked Plating System Line Extension of Cable Plugs | Howmedica Osteonics Corp | HRS | Class II | |
| K092153 | Skyline 55, Model Ver 1 | Larsen & Toubro Limited | MWI | Class II | |
| K092050 | Immunocap Allergen D201, House Dust Mite, Model 4-4896-01 | Phadia AB | DHB | Class II | |
| K091862 | Nessi Spacer | Pharmacaribe LLC | NVO | Class II | |
| K091814 | Fora D20 Blood Glucose Plus Blood Pressure Monitoring System; Td-3263 Blood Glucose Plus Blood Pressure Monitoring Syste | Taidoc Technology Corporation | CGA | Class II | |
| K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products Ltd. | QSY | Unclassified | |
| K091468 | IVD Technologies Achrab Test Kit | Ivd Technologies | NST | Class II | |
| K091053 | Proparaflu+assay | Prodesse, Inc. | OOU | Class II | |
| K090780 | Medtrade Products Celox Topical Hemostatic Paste | Medtrade Products Ltd. | QSY | Unclassified | |
| K090195 | Palomar Lux1540 Handpiece | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K083754 | Mini Lap Electrocautery Instruments | Mini Lap Technologies, Inc. | GEI | Class II | |
| K093399 | Precisecore 10 Mm Biopsy Device- 14Ga X 5 Cm Model 670514, 671014, 670518 671018, 670520 | Inrad | KNW | Class II | |
| K092797 | Acute and Chronic Catheter Repair Kit | Kendall | NFK | Class II |