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 |
|---|---|---|---|---|---|
| K881168 | Creatine Kinase (Ck) Isoenzyme Mb | Data Medical Associates, Inc. | JHT | Class II | |
| K884465 | Spirometrics Model 2141 Spiro-Filter(tm) | Spirometrics, Inc. | CAH | Class II | |
| K884009 | Model 459 Electrocardiocorder Recorder | Del Mar Avionics | DSH | Class II | |
| K883973 | Model Vy-800Ra Optional Accessory to Bsm 8500A | Nihon Kohden America Inc | DXJ | Class II | |
| K883930 | Seamed Model 3300 Dual Chamber Pacing System Analy | Seamed Corp. | DTE | Class II | |
| K883843 | Cardiobeeper II | Survival Technology, Inc. | DXH | Class II | |
| K883304 | Traid-Ep, Plate Input, W/pulse Blanking Circuitry | Cardiotronics, Inc. | DRO | Class II | |
| K883215 | Kirschner Tc-Iv/non Por Coat/total Condylar Knee S | Kirschner Medical Corp. | JWH | Class II | |
| K883178 | Triad-Ep, Pushbutton, Cable Input Type | Cardiotronics, Inc. | DRO | Class II | |
| K882635 | Electronic Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | DXN | Class II | |
| K882254 | Oec-7102 Ecg/nibp Monitor | Nihon Kohden America Inc | DPS | Class II | |
| K881954 | Concept Power System | Concept, Inc. | HSZ | Class I | |
| K881772 | Sensocor(tm) R-Test 240 Xl | Sensormedix, Inc. | DXH | Class II | |
| K884435 | Resubmitted 1,3 & 4 Way Stopcocks, Various Parts | Clinical Connections, Inc. | FMG | Class II | |
| K884404 | Herniastat | Innovative Surgical Devices Corp. | GAG | Class II | |
| K884380 | Bed Sheet, Pillow Case | Saybrex Intl., Inc. | KME | Class I | |
| K884373 | Korber Arteriotomy Scissors | Micrins, Ltd. | LRW | Class I | |
| K884295 | Surgical Apparel, Isolation Gown,mask,cap,sleeve | Saybrex Intl., Inc. | LGM | Class II | |
| K884255 | Concept Cct-5200, Thermal Therapy System | Concept, Inc. | ILO | Class II | |
| K884196 | Surgical Instruments (Various Types & Sizes) | Disposable Sterile Surgical Instruments, Inc. | HRQ | Class I | |
| K883587 | Biosearch 3600 Entri Feeding Pump | Biosearch Medical Products, Inc. | FRN | Class II | |
| K883471 | Vkg 1000, Video Keratometer | Technitex, Inc. | HLP | Class I | |
| K882723 | Alcon Fluid Injector | Alcon Laboratories | DQF | Class II | |
| K882715 | Sterile Surgical Latex Gloves | Plastic Materials of Puerto Rico, Inc. | KGO | Class I | |
| K881725 | Envirotent (Bed) | Envirotents, Inc. | FNJ | Class I | |
| K880723 | Dimension Whole Blood Cholesterol | Technimed, Inc. | CHH | Class I | |
| K884370 | Cms IV Extension Sets | Vygon Mfg | FPK | Class II | |
| K884341 | Critical Care i.v. Stand Stabilizing Bracket | Rbd Medical, Inc. | FOX | Class I | |
| K884030 | Ergo II, Surgical Latex Gloves | Ergo Intl., Ent., Inc. | KGO | Class I | |
| K883787 | Reusable Adult Incontinent Diaper | Intera Corp. | EYQ | Class I | |
| K883664 | Lum Vascular Procedure System #B5200a | General Electric Co. | IYB | Class I | |
| K883573 | Thermometer, Mercury/clinical | Umax Corp. | FLK | Class II | |
| K883458 | Optimed Advantage | Optimed, Inc. | HPT | Class I | |
| K883260 | Dittmar Power Lifter | Dittmar and Penn Corp. | FOX | Class I | |
| K882875 | Stereotactic Breast Lesion Localization Accessory | Lorad Medical Systems, Inc. | IZH | Class II | |
| K882138 | Imexlab 3000 Vascular Diagnostic Recorder | Imex Medical Systems, Inc. | DPW | Class II | |
| K884400 | Anti-Native DNA Antibody Test (Crithidia Luciliae) | Immco Diagnostics, Inc. | DHN | Class II | |
| K884217 | Technicon Dpa-1 Analyte Alpha 1 Acid Glycoprotein | Technicon Instruments Corp. | LKL | Class I | |
| K884060 | Meditec Ql-15 Nd:yag Laser | Storz Ophthalmics, Inc. | GEX | Class II | |
| K883923 | Cardiotomy/venous Reservoir No.: Cvr Series | Gish Biomedical, Inc. | DTN | Class II | |
| K883834 | Medrad Omniplane 300 System | Medrad, Inc. | KPR | Class II | |
| K883722 | Ciba Corning Magic Lite Vitamin B12 Immunoassay | Ciba Corning Diagnostics Corp. | CDD | Class II | |
| K883579 | Coronary Guide Wire | Datascope Corp. | DQX | Class II | |
| K883541 | Metalaser Vasculase | Metatech Corp. | GEX | Class II | |
| K883537 | Qm300 Control E | Kallestad Diag, A Div. of Erbamont, Inc. | DHB | Class II | |
| K883532 | Icor Agent Monitor | Icor AB | CBQ | Class II | |
| K883481 | Hp 77025A/77030a Ultra. System/hp 77020Cv Upgrade | Hewlett-Packard Co. | IYO | Class II | |
| K882974 | Force Guard I | Boulder Impact Monitors, Inc. | IRN | Class II | |
| K882939 | Niobi-X Radiation Reduction Filter | American Canadian Products, Inc. | ITY | Class I | |
| K882151 | Port-O-Heat, Model 0100 | Arthotronics, Inc. | IRT | Class II |