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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K842369 | Elecath Infant Arterial & Venous Cannu | Electro-Catheter Corp. | BWF | Class II | |
| K842312 | Servocard Scp-840 | Litton Datamedix | LDD | Class II | |
| K842302 | Fluid Warmer | bioMerieux, Inc. | FLA | Class II | |
| K842235 | Servocard Defibrillator Scp-851 | Litton Datamedix | LDD | Class II | |
| K842194 | Pressure Monitor | Norton Texas Medical Products | DXS | Class II | |
| K842139 | The Denver Pleural-Peritoneal Shunt | Denver Biomedicals, Inc. | KPM | Class II | |
| K841629 | Drill Bit | Plastafil, Inc. | HTW | Class I | |
| K841627 | Mallet | Plastafil, Inc. | HWA | Class I | |
| K841626 | Punch | Plastafil, Inc. | HXG | Class I | |
| K841625 | Hook | Plastafil, Inc. | GAD | Class I | |
| K841624 | Probe | Plastafil, Inc. | HRX | Class II | |
| K841618 | Threading Tube | Plastafil, Inc. | FZX | Class I | |
| K841617 | Strover Hook | Plastafil, Inc. | HCF | Class I | |
| K840391 | Angiographic Procedure Tray | Triad Medical Division | DQX | Class II | |
| K831809 | Fogarty Occluder Pad | Thomas J. Fogarty, M.D. | DXC | Class II | |
| K843221 | Megason Model 150 | Birtcher Corp. | IMI | Class II | |
| K843213 | Qualine Wheelchair Products | Contemporary Health Sys | IQC | Class II | |
| K843155 | Sure & Natural Deodorant Maxi-Shield | Johnson & Johnson Professionals, Inc. | HHL | Class II | |
| K843073 | Fixed Vol. Dispensers, Adjust Vol-Hunpip | Greene International Corp. | JQW | Class I | |
| K843071 | Esophageal Stethoscopes W/elec Conductor | Primrose Medical, Inc. | BZT | Class II | |
| K843070 | Esophageal Stethoscopes | Primrose Medical, Inc. | BZW | Class I | |
| K843061 | Tambrands Inc. Ill.p. 2 | Tambrands Inc. | HHD | Class I | |
| K843022 | Kerr Command Ultrafine Polishing Paste | Kerr Corporation (Danbury) | EJR | Class I | |
| K843009 | Bp-1000 | Pollenex Associated Mills, Inc. | DXN | Class II | |
| K842978 | 540 Capnograph | Spacelabs, Inc. | CCK | Class II | |
| K842906 | Bias Total Hip | Zimmer GmbH | JDI | Class II | |
| K842875 | Rionet Hearing Aid Hb-35 | Rion Acoustic Instruments, Inc. | ESD | Class I | |
| K842580 | Accessory for Adult Vol. Ventilator | Infrasonics Corp. | CAH | Class II | |
| K842486 | Electronic Digital Bp Meter Hc 3001 | North American Philips Corp. | DXN | Class II | |
| K842314 | Duoclon Color-Cept | Organon LLC | JHJ | Class II | |
| K842186 | Acu-Derm Transparent Wound Dressing | Acme United Corp. | NAD | Class I | |
| K842055 | Picker Artis Ultrasound Imaging Sys | Philips North America LLC | IYN | Class II | |
| K841850 | Custom Sterile Procedure Trays-Multi | Sterilco, Inc. | |||
| K841769 | Intermittent Urethral Catheter Tray | Seamless Hospital Products Co. | KOD | Class II | |
| K841357 | Micro Fluid Applicator | Treace Medical, Inc. | JZF | Class I | |
| K841095 | Bp800, 850 1000 | Associated Mills, Inc. | DXN | Class II | |
| K841041 | Clini-Tek Auto 2000 Reflectance Spectr | Miles Laboratories, Inc. | KQO | Class I | |
| K833737 | CPR Locator | Lifepoint,Inc | LIX | Class II | |
| K843262 | Transesophageal Echocardiography Ultraso | Hewlett-Packard Co. | JOP | Class II | |
| K842951 | Maxithins Body-Shaped Panty Shields | Tambrands Inc. | HHD | Class I | |
| K842950 | Super Maxithins Body-Shaped Maxi Pads | Tambrands Inc. | HHD | Class I | |
| K842839 | Serimm Sure Aso-Chek Control Serum | Analytical Products, Inc. | GTQ | Class I | |
| K842633 | Tandem Fast Visual Hcg Assay Kit - | Hybritech, Inc. | JHI | Class II | |
| K842434 | Behing the Ear Hearing Aid T-98 | Bernafon LLC | ESD | Class I | |
| K842253 | Augmentin 30 Mcg Sensi Disc | BD Becton Dickinson Vacutainer Systems Preanalytic | JTN | Class II | |
| K842074 | Earette Hearing Aid Oticon E30v | Oticon, Inc. | ESD | Class I | |
| K842073 | Earette Hearing Aid Oticon E31v | Oticon, Inc. | ESD | Class I | |
| K841369 | Beta Scan Drystix | Orange Medical Instruments, Inc. | CGA | Class II | |
| K840140 | Doppler Imaging Option | Hewlett-Packard Co. | IYN | Class II | |
| K834408 | Tx-2 Thermal Dilution Cardiac Output | Waters Instruments, Inc. | DXG | Class II |