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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K812405 | Sterile Tv Camera & Cord Cover | Hydro-Med Products, Inc. | KQM | Class I | |
| K812256 | Model Ap 180 Mini-Monitor | Sonicaid, Inc. | HGM | Class II | |
| K812020 | Egnell Compact, Type Ehv | Egnell, Inc. | BTA | Class II | |
| K810338 | Lympha Press | Mego Afek | JOW | Class II | |
| K812777 | Direct Iron Reagent Set | The Dow Chemical Co. | JIY | Class I | |
| K812772 | Peritoneal Dialysis Cycler Set (8Unit) | Dravon Medical, Inc. | KDJ | Class II | |
| K812771 | Peritoneal Dialysis Drainage | Dravon Medical, Inc. | KDJ | Class II | |
| K812759 | Nml Ck-Mb Ria | Nuclear Medical Laboratories, Inc. | JHX | Class II | |
| K812754 | Beckman Astra Systems Direct Bilirubin | Beckman Instruments, Inc. | CIG | Class II | |
| K812753 | Ames Tda Quinidine Test | Miles Laboratories, Inc. | LBZ | Class II | |
| K812749 | Ultra-Dig | Antibodies, Inc. | LCS | Class II | |
| K812734 | Machida Flexible Intubation Scope Fls-P | Machida America, Inc. | EQN | Class II | |
| K812732 | Septi-Chek Bh1 Blood Culture Bottle | Hoffmann-La Roche, Inc. | JSG | Class I | |
| K812731 | Septi-Check Blood Culture Slide | Hoffmann-La Roche, Inc. | JSI | Class I | |
| K812729 | Septi-Chek Blood Culture Bottle Roche | Hoffmann-La Roche, Inc. | JSG | Class I | |
| K812718 | Cuff Material on Pediatric Size Cath. | Quinton, Inc. | FJS | Class II | |
| K812717 | Non-Sterile Shadow-Stripe Catheter | Quinton, Inc. | FKO | Class II | |
| K812704 | Neuromed Selectra #7720 | Medtronic, Inc. | GZJ | Class II | |
| K812650 | Beckman Ics Normal Control Sera | Beckman Instruments, Inc. | JJY | Class I | |
| K812649 | Beckman Ics Calibrator | Beckman Instruments, Inc. | JIX | Class II | |
| K812620 | Adjustable Microsurgical Knife | Vxtra Corp. | HNN | Class I | |
| K812597 | Ferritin Kit | Hybritech, Inc. | DBF | Class II | |
| K812588 | Scanner 700 | National Ultrasound Corp. | IYO | Class II | |
| K812577 | Unscented Menstrual Pads | Weyerhaeuser Co. | HHD | Class I | |
| K812575 | Model H12-10 | Hospal Medical Corp. | KDI | Class II | |
| K812542 | Polaroid Instant Endocamera | Polaroid Corp. | FEM | Class I | |
| K812535 | Plastilix Minirad D Cassette | Eastman Kodak Company | IXA | Class II | |
| K812201 | Photographic Equipment | Reznik Instruments | FEM | Class I | |
| K811951 | Dressing Change Trays & Sterile Sponges | O.R. Specialties, Inc. | EFQ | Unclassified | |
| K812532 | Temp-Fill | Madrid Uso, Jr., D.D.S. | EMA | Class II | |
| K812529 | Earscan | Micro Audiometrics Corporation | EWO | Class II | |
| K811916 | Operating Room Kit | American Hospital Supply | FSM | Class I | |
| K811737 | Bio-Tone Model 4 | Biotone International, Inc. | IPF | Class II | |
| K802342 | Proximal Interphalangeal Joint Implant | Sutter Biomedical, Inc. | JDI | Class II | |
| K812723 | Pearce Corneal Trephine | Visitec Co. | HRH | Class I | |
| K812715 | Teca #Te 8 | Teca, Inc. | IKN | Class II | |
| K812701 | Ortho-Therm Infrared Sensor | Orthion Corp. | IYM | Class III | |
| K812695 | Disk | American Heartline, Inc. | |||
| K812693 | Lif-O-Gen #3000 Oxygen Concentrator | Lif-O-Gen, Inc. | CAW | Class II | |
| K812683 | Neonate Flexfloat | Pharmaquest Corp. | FOH | Class I | |
| K812676 | Amplitone-3 | Progressive Technology, Inc. | LDE | Class I | |
| K812675 | Disposable Surgical Face Masks | Irema USA, Ltd. | FXX | Class II | |
| K812674 | Infant Caridac Monitor | Electromed Intl., Ltd. | DRT | Class II | |
| K812616 | Polyphos 500 | Siemens Corp. | IZO | Class I | |
| K812606 | Sectortac | Echo Laboratories, Inc. | IYN | Class II | |
| K812561 | Lateral Angulating Fluoro Suspension Sys | General Electric Co. | JAA | Class II | |
| K812539 | Pre-Bypass Filter | Gelman Sciences, Inc. | KRJ | Class II | |
| K812530 | Transducer Dome | Biomeal Corp. | DRS | Class II | |
| K812517 | Cardiac Pacing Electrodes | Medics Instrument Corp. | LDF | Class II | |
| K812509 | Ct/t 8800 | General Electric Co. | JAK | Class II |