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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K891556 | Exam Gloves (Vinyl) Mfg. Glorious Wealth Co. | Green Light Import Export Co., Inc. | ESD | Class I | |
| K900736 | Bulb Irrigation Tray | Orion Life Systems, Inc. | EYN | Class II | |
| K900229 | Bard Conformacath Foley Catheter | C.R. Bard Inc | KOD | Class II | |
| K896041 | Gesco Dual Lumen Umbilicath II-Dl | Gesco Intl., Inc. | FOS | Class II | |
| K895030 | Life-Line(tm) Vascular Access System | Medical Engineering and Development Institute | LJT | Class II | |
| K901586 | Tri-Rolls Rear Wheel Drive Powered Scooter | Invacare GmbH | INI | Class II | |
| K901470 | Sears Model Jcs in-the-Ear Hearing Instrument | Miracle-Ear, Inc. | ESD | Class I | |
| K901469 | Sears Model Lf9096 in-the-Ear Hearing Instrument | Miracle-Ear, Inc. | ESD | Class I | |
| K901390 | Dmac Indole Reagent | Analytical Products, Inc. | JTO | Class I | |
| K901389 | Sears Model Lc9092 in-the-Ear Hearing Instrument | Miracle-Ear, Inc. | ESD | Class I | |
| K901388 | Sears Model Lm9091 in-the-Ear Hearing Instrument | Miracle-Ear, Inc. | ESD | Class I | |
| K901387 | Sears Model Li9097 in-the-Ear Hearing Instrument | Miracle-Ear, Inc. | ESD | Class I | |
| K901381 | Superarm 2000 Lift | Handicaps, Inc. | ING | Class II | |
| K901346 | Es 300 Immunoassay System | Boehringer Mannheim Corp. | JJE | Class I | |
| K901264 | Coulter Gamma-Gt (Ggt) Reagent | Coulter Corp. | JQB | Class I | |
| K901201 | Trojan Ribbed Latex Condoms W/sperm. Modified | Carter Products | HIS | Class II | |
| K901200 | Trojan for Women Latex Condoms W/spermi. Modified | Carter Products | HIS | Class II | |
| K901199 | Trojan-Enz Latex Condoms W/spermicidal Modified | Carter Products | HIS | Class II | |
| K901198 | Trojan Plus 2 Latex Condoms W/spermicidal Modified | Carter Products | HIS | Class II | |
| K901197 | Trojan Extra Strength Lubri. Condoms Modi. Label | Carter Products | HIS | Class II | |
| K901196 | Trojan for Women Lubri. Condoms Modified Labeling | Carter Products | HIS | Class II | |
| K901195 | Trojan Ribbed Naturalube Lubri. Condoms Modified | Carter Products | HIS | Class II | |
| K901194 | Trojan Ribbed Lubri. Latex Condoms Modified Label | Carter Products | HIS | Class II | |
| K901193 | Trojan Plus Lubri. Latex Condoms (Modified Label) | Carter Products | HIS | Class II | |
| K901192 | Trojan-Enz Lubri. Condoms (Modified Labeling) | Carter Products | HIS | Class II | |
| K901191 | Trojan-Enz Latex Condoms (Modified Labeling) | Carter Products | HIS | Class II | |
| K901190 | Trojans Latex Condoms (Modified Labeling) | Carter Products | HIS | Class II | |
| K901177 | Discoid/cleoid Double End Amalgam Carver | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901176 | #23 Explorer | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901175 | Hand Mirror | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901174 | Elevator #11 | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901173 | Discoid Spoon Excavator | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901172 | Gracey Curette #13-14 | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901171 | U-15 Single End Scaler | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901170 | Periodontal Knife | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901169 | 5 Straight Scissors | American Medical Ceramics, Inc. | EKJ | Class I | |
| K901155 | Duoderm* Control Gel Formula Border Dressing | Convatec, A Division of E.R. Squibb & Sons | KMF | Class I | |
| K901083 | Emds(tm) Cerebrospinal Fluid Protein, #67668/95 | Em Diagnostic Systems, Inc. | JGQ | Class II | |
| K901052 | Pulpdent Oil Free Surface Preparation Paste | Pulpdent Corporation | EJR | Class I | |
| K901003 | Boehringer Mannheim/hitachi 747 Chemistry Analyzer | Boehringer Mannheim Corp. | JJE | Class I | |
| K900993 | Chem-Chex | Streck Laboratories, Inc. | JJY | Class I | |
| K900974 | Indirect Fluorescent Assay for (Ebv-Vca) Igg Anti. | Stellar Bio Systems, Inc. | JRY | Class I | |
| K900917 | Coag-a-Mate - Ra4 | bioMerieux, Inc. | JPA | Class II | |
| K900895 | Coag-a-Mate - Ra4 | bioMerieux, Inc. | KQJ | Class II | |
| K900870 | Pathodx Chlamydia Trachomatis Direct Specimen Test | Siemens Healthcare Diagnostics Inc. | LJP | Class I | |
| K900844 | Wedjets | The Hygenic Company, LLC | EIE | Class I | |
| K900785 | Micro 2 System | Inodent | EGG | Class I | |
| K900685 | Clot 2 Semiautomatic Coagulation Analyzer | Texas Intl. Laboratories, Inc. | KQG | Class II | |
| K900684 | Rdw and Mpv Indices on Hemat 12 | Texas Intl. Laboratories, Inc. | GKZ | Class II | |
| K900669 | Hypo-Allergenic Surgical Gloves | Modern Rubber Industrial Co., Ltd. | KGO | Class I |