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 |
|---|---|---|---|---|---|
| K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | CIL | Class II | |
| K895738 | Micromedics Ear, Nose and Throat Burs | Micromedics, Inc. | EQJ | Class I | |
| K895659 | Hui Mini-Flex | Unimar, Inc. | HIG | Class II | |
| K895070 | Select White | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895069 | Select 40 | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895067 | Select 60 | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895063 | 450 Sl (Silhouette Line) Dental Casting Alloys | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895060 | 750 Sl (Silhouette Line) Dental Casting Alloys | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895056 | Low Fusing White Gold | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895054 | .650 Fine Gold Solder | Leach and Dillon Co., Inc. | EJT | Class II | |
| K894175 | Sri Human Chorionic Gonadotropin Immunoenz Assay | Serono-Baker Diagnostics, Inc. | JHI | Class II | |
| K893879 | Sys*stim 207A | Mettler Electronics Corp | IPF | Class II | |
| K893878 | Sys*stim 206A | Mettler Electronics Corp | IPF | Class II | |
| K891691 | Lyphochek Urine Metals Control, Levels I and II | Bio-Rad | DIE | Class I | |
| K896852 | Ventrex Coated Tube Ige Enzyme Immunoassay | Ventrex Laboratories, Inc. | DHB | Class II | |
| K896398 | Difco Oxidase Dryslide | Difco Laboratories, Inc. | JTO | Class I | |
| K896350 | Titan Air Spectacle Frame | Acces Intl. Eyewear | HQJ | Class II | |
| K896305 | Multi-Use I/a Handpiece | Advanced Surgical Products, Inc. | HQE | Class II | |
| K896275 | Jedmed J-II Chair | JEDMED Instrument Company | FRK | Class I | |
| K896198 | Mainster Wide Field Laser Lens | Ocular Instruments, Inc. | HJK | Class II | |
| K896169 | Metal Ureteral Basket Stone Dislodger | Annex Medical, Inc. | FFL | Class II | |
| K895846 | Two Mirror Gonio Lens | Ocular Instruments, Inc. | HKS | Class I | |
| K895807 | Sterile Examination Gloves, Hypo-Allergenic' | Safeskin Corp. | LYY | Class I | |
| K895742 | Liteline Vlc Soft Reline | Dentsply Intl. | EBI | Class II | |
| K895736 | Lynx-High Speed Handpiece | Mti Precision Products | EFB | Class I | |
| K895652 | Ebv-Ea Ifa Kit | Organon Teknika Treyburn | LSE | Class I | |
| K895647 | 5.0 Mhz Convex Array Intravaginal Transducer | Advanced Technology Laboratories, Inc. | HGL | Class II | |
| K895276 | Diatech Igm-Mp Test | Diatech Diagnostica, Ltd. | LJZ | Class I | |
| K895068 | Select 50 | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895065 | Monogram III | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895064 | Monogram II | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895062 | 500 Sl (Silhouette Line) Dental Casting Alloys | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895061 | 700 Sl (Silhouette Line) Dental Casting Alloys | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895057 | High Fusing White Gold | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895055 | .730 Fine Gold Solder | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895053 | .615 Fine Gold Solder | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895052 | .585 Fine Gold Solder | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895051 | Monogram I | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895050 | 100 Sl (Silhouette Line) Dental Casting Alloys | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895049 | 200 Sl (Silhouette Line) Dental Casting Alloys | Leach and Dillon Co., Inc. | EJT | Class II | |
| K895048 | 300 Sl (Silhouette Line) Dental Casting Alloys | Leach and Dillon Co., Inc. | EJT | Class II | |
| K894533 | Condom (Rubber Latex) Kilroy | Rfsu | HIS | Class II | |
| K893230 | Detectadot Tm System 2000 Cmv Igm Test | Gull Laboratories, Inc. | LFZ | Class II | |
| K893200 | Detectadot (Tm) System 2000 Toxo Igm Test | Gull Laboratories, Inc. | LGD | Class II | |
| K895712 | Percutaneous Intravenous Catheters | Pharmacia Deltec, Inc. | LJS | Class II | |
| K894611 | Catheter Care Kits | L H M Ent., Inc. | FOZ | Class II | |
| K896745 | Jaw Blocker | Plastic Engineered Products Co. | JXL | Class II | |
| K896472 | Key Vascular Booties | Key Surgical, LLC | MAW | Class I | |
| K896289 | Radiation Protection Apron | Infab, LLC. | KPY | Class I | |
| K896050 | Fuji Computed Radiography System Fcr Ac-1 (Fcr) | FUJIFILM Healthcare Americas Corporation | LLZ | Class II |