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 |
|---|---|---|---|---|---|
| K012559 | Poly Stat Hcg Test | Bion Diagnostic Sciences | JHI | Class II | |
| K012542 | Revotek Lc | GC America Inc. | EBC | Class II | |
| K012499 | Environ-Np Powder Free Synthetic Vinyl Examination Gloves | Shanghai Antares Industries, Inc. | LYZ | Class I | |
| K012482 | Storz Modulith Slk Lithotripter with Multiview Option | Karl Storz Endoscopy-America, Inc. | LNS | Class II | |
| K012346 | Vanguard Reprocessed Arthroscopic Blades | Stryker Sustainability Solutions | HRX | Class II | |
| K012339 | Enviorn-Np Powder Free Synthetic Vinyl Examination Gloves, Yellow | Shanghai Antares Industries, Inc. | LYZ | Class I | |
| K012254 | Vbr | Osteotech Inc | MQP | Class II | |
| K011530 | Vertran Standing Wheelchair | Fena Design, Inc. | IPL | Class II | |
| K011337 | Ultegra System Rapid Platelet Function Assay (Rpfa) | Accumetrics, Inc. | JOZ | Class II | |
| K013164 | Surshield Safety Winged Blood Collection Set | Terumo Medical Corp. | FPA | Class II | |
| K013134 | Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2kun6 (600 Tests) | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K013121 | Mt Alert Infusion Monitor | Sierra Biosearch, Inc. | FLN | Class II | |
| K013118 | Modification to Alpha Dx System | First Medical, Inc. | JHX | Class II | |
| K013026 | Powdered Latex Examination Gloves | Great Glove (Thailand) Co., Ltd. | LYY | Class I | |
| K012668 | Raichem Glucose UV Reagent | Hemagen Diagnostics, Inc. | CFR | Class II | |
| K012649 | Raichem Bun Rate Reagent | Hemagen Diagnostics, Inc. | CDQ | Class II | |
| K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | LJS | Class II | |
| K012595 | Acon Mtd One Step Methadone Test Strip and Test Device | Acon Laboratories, Inc. | DJR | Class II | |
| K012384 | Ear Muffins | Bio-Logic Systems Corp. | HCC | Class II | |
| K012358 | Chiba Needle | Ispg, Inc. | FCG | Class II | |
| K012240 | Mertex-Plus O.r./surgeons Gown, Nonsterile | Mercan AB | FYA | Class II | |
| K012237 | Mertex-Plus Reusable Surgical Drape | Mercan AB | KKX | Class II | |
| K011283 | Monoject Prefill 0.9% Sodium Chloride Flush Syringe | Kendall | NGT | Class II | |
| K010997 | Pam-Rl | Individual Monitoring Systems, Inc. | GWQ | Class II | |
| K002512 | Toraysulfone Dialyzer | Toray Industries (America), Inc. | KDI | Class II | |
| K013286 | Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove Lined with Aloe Vera | Tillotson Healthcare Corp. | LYY | Class I | |
| K013229 | Liferay Fw Mammo Cassette, Liferay Kw Mammo Casette | Ferrania USA, Inc. | IXA | Class II | |
| K013179 | Luxaglaze | Dmg USA, Inc. | EBD | Class II | |
| K013057 | Biocuff,c, Models 236018, 236028, 236036 | Bionx Implants, Inc. | MAI | Class II | |
| K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System | Boston Scientific Corporation | ESW | Class II | |
| K012425 | Biomedics UV Multifocal | Ocular Sciences Puerto Rico, Inc. | LPL | Class II | |
| K012404 | K-Defib/pace Adult Electrode, Model Kdp-85 | Katecho LLC | DRO | Class II | |
| K012402 | Omni Grace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim | Omnigrace (Thailand), Ltd. | LYY | Class I | |
| K012218 | Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes | The Ludlow Company LP | DRO | Class II | |
| K012206 | Alternanas Processing System, Ch 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System | Cambridge Heart, Inc. | DQK | Class II | |
| K011470 | Sdi Sb Office, Model 29- | Sdi Diagnostics, Inc. | BZG | Class II | |
| K011373 | Instrument Damping Port | Medcanica, Inc. | DRC | Class II | |
| K010615 | Cyclotec Amt Cti TENS Device | Cyclotec | GZJ | Class II | |
| K010613 | Magellan-2200, Model 1 | Oceanic Medical Products, Inc. | BSZ | Class II | |
| K004005 | Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis System (Proposed) | Mentor | QPB | Class II | |
| K013043 | Candela Clearbeam Pulsed Dye Laser | Candela Corporation | GEX | Class II | |
| K012935 | Thecurve, Item 507 | Select Medical Systems, Inc. | MFD | Class II | |
| K012807 | Modification to: Compel Surgical Drapes | Standard Textile Co., Inc. | KKX | Class II | |
| K012315 | Leveen Electrode | Radiotherapeutics Corp. | GEI | Class II | |
| K011080 | Bridge Se Self-Expanding Stent Delivery System | Medtronic, Inc. | FGE | Class II | |
| K010869 | Epoca Custom Offset Shoulder System | Argomedical AG | KWT | Class II | |
| K003811 | Cryocare Surgical System | Varian Medical Systems, Inc. | GEH | Class II | |
| K013194 | Unimark Hcg Combo Pregnancy Test | Biotech Atlantic, Inc. | JHI | Class II | |
| K013140 | Rhodia Hydrophilic Dental Impression Material | Rhodia, Inc. | ELW | Class II | |
| K013129 | Rhodia Dental Putty Impression Material | Rhodia, Inc. | ELW | Class II |