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 |
|---|---|---|---|---|---|
| K810968 | Bcd-Hpp41c Interface | Dynatech Corp. | JQP | Class I | |
| K810967 | In-Vitro Tbg Radioimmunoassay Test | Clinical Assays, Inc. | CEE | Class II | |
| K810960 | Nasopharyngeal Airway | Vesta, Inc. | BTQ | Class I | |
| K810953 | Model 533 Phototherapy Unit | Narco Air-Shields | LBI | Class II | |
| K810951 | Reagents for Quant. Enzymatic Deter.-Tr. | Mid Tech, Inc. | |||
| K810944 | Penile Erection Monitor | Medical Monitoring Systems, Inc. | LIL | Unclassified | |
| K810939 | Nebulizer/humidifier Humidity Center-Mi. | Allied Medical LLC | BTT | Class II | |
| K810938 | Mass Spectrometer-Medspect II | Allied Medical LLC | DOP | Class I | |
| K810925 | Naturalyte Bicarbonate Dialysate Concen. | Erika, Inc. | KPO | Class II | |
| K810919 | Hemoglobin Electrophoresis Control | Isolab, Inc. | JBD | Class II | |
| K810912 | Alloy Composite Polish | Moyco Industries, Inc. | EJR | Class I | |
| K810907 | Coltene Orally | Coltene, Inc. | EJJ | Class II | |
| K810888 | Boundary Tubing Holders | The Buckeye Cellulose Corp. | FZX | Class I | |
| K810886 | Adel Medical Birthing Bed, #Ld-500 | Adel Medical, Ltd. | HDD | Class II | |
| K810883 | Omed Silicone Instrument Covers | Omega-Med Intl., Inc. | KDC | Class I | |
| K810874 | Fetal Calf Serum | Tissue Culture Biologicals | KIS | Class I | |
| K810873 | Star | Intl. General Electric Co. | JWM | Class II | |
| K810851 | Spectrum Analyzer 8000 | Radionics Medical, Inc. | DXG | Class II | |
| K810848 | Cytobucket Model 1024 | Cytochem, Inc. | IFB | Class I | |
| K810836 | Decalcifier II | Surgipath | KDX | Class I | |
| K810817 | Exeter Operating Loupe | Exeter Instruments, Inc. | HOH | Class I | |
| K810721 | Process Change | Medlon, Inc. | FPA | Class II | |
| K810716 | X-Ray Image Intensifier Products | Instrumentation Camera, Inc. | JAA | Class II | |
| K810690 | Curity 100% Silicone Safety Indicator | The Kendal Co. | KOD | Class II | |
| K810688 | The Sunfactory | Wesgold Marketing, Inc. | FTC | Class II | |
| K810668 | Ho-B-Lite VI Unit | National Biological Corp. | KGL | Class II | |
| K810637 | Cobe Disposable Pressure Transducer | Cobe Laboratories, Inc. | DRS | Class II | |
| K810573 | Tube Feeding Set | Harvard Laboratories | KNT | Class II | |
| K810551 | Pacemaker Lead Adapter | Pacesetter Systems | DTD | Class II | |
| K810532 | Disposable Stopcock | Texas Medical Products, Inc. | DTZ | Class II | |
| K810529 | Direct Writing Vectorcardiograph | Elmed, Inc. | DYC | Class II | |
| K810527 | Chem-Dialyte Concentrates | Luchem Pharmaceuticals, Inc. | KPO | Class II | |
| K810515 | Disposable 2-Stage Cannula | Texas Medical Products, Inc. | DWF | Class II | |
| K810505 | Cardiopulmonary Bypass Oxygenator | Cobe Laboratories, Inc. | DTZ | Class II | |
| K810476 | B.j.'s Uva Sun Tan Bed W/sun Roof | B.J. Ent. | FTC | Class II | |
| K810016 | Replacable Battery Perfectemp Cautery | Medical Products Development, Inc. | HQP | Class II | |
| K810013 | Multiperfectemp Cautery | Medical Products Development, Inc. | HQP | Class II | |
| K810012 | Multimicro Surgical Cautery | Medical Products Development, Inc. | HQP | Class II | |
| K803238 | Intravascular Catheter | G.D. Searle and Co. | FOZ | Class II | |
| K802958 | Auto Refractometer Nr-1000 | Nippon Kogaku, Inc. | HKO | Class I | |
| K802635 | Ophthalmo Echograph Model Zd255g | JEDMED Instrument Company | IYO | Class II | |
| K802183 | Sr-IV Programmed Subjective Refractor | American Optical Corp. | HKO | Class I | |
| K810966 | Diagoxin Squibb Radioimmunoassay Kit | E. R. Squibb & Sons, Inc. | DNL | Class II | |
| K810959 | Secure | Sci-Pharm, Inc. | DYH | Class II | |
| K810954 | Norfolk/norwich Pressure Infusion Box | Medical Innovations, Inc. | KZD | Class I | |
| K810923 | Lee Endofill, Root Canal Filling Resin | Lee Pharmaceuticals | KIF | Class II | |
| K810900 | Castle Procedure and Ritter Exam. Tables | Sybron Corp. | LGX | Class I | |
| K810864 | Water Pik Oral Hygiene Center | Teledyne, Inc. | EFS | Class I | |
| K810855 | Interface 20 Micron Transfusion Bld. F. | Abbott Medical | CAK | Class II | |
| K810822 | Dental Porcelain Powder | Coors Biomedical Co. | EIH | Class II |