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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K012489 | Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models Pl-12-12-09, Pl-12-12-10 | Appriva Medical, Inc. | DYB | Class II | |
| K012488 | Modification To:endius Bipolar Sheath | Endius, Inc. | GEI | Class II | |
| K012341 | Translux Energy | Kulzer GmbH | EBZ | Class II | |
| K012322 | Optibond 2 | Sybron Dental Specialties, Inc. | KLE | Class II | |
| K012253 | Ssd-1000 Diagnostic Ultrasound System | Aloka Co., Ltd. | IYO | Class II | |
| K012169 | Ilt Support Catheter .014, Model C114lw1; Ilt Support Catheter Advancing Mechanism, Model A11am1 | Intra Luminal Therapeutics, Inc. | DQY | Class II | |
| K011983 | Insight Genesis | Fasstech | HCC | Class II | |
| K011775 | Micro Targeting Drive System | FHC, Inc. | HAW | Class II | |
| K011769 | Opus 10 (with Tooth Whitening Application), Model 2Nd | Opusdent, Ltd. | GEX | Class II | |
| K011747 | Palomar Lc 100 Diode Laser | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K011745 | Hp-3, Battetry Operated, Font Wheel Drive, Power Wheelchair | Transworld Mobility Distribution, LLC | ITI | Class II | |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000 | Dni Nevada, Inc. | DTC | Class II | |
| K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | GEI | Class II | |
| K011716 | The Uni-Clip Staple | New Deal, S.A. | JDR | Class II | |
| K010968 | Vectorvision Ct/fluoro | Brainlab, Inc. | HAW | Class II | |
| K010404 | Exel i.v. Administration Set | Exelint Intl. Co. | FPA | Class II | |
| K003804 | Sensi-Prema Neonatal ECG Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 | Niko Medical Products | DRX | Class II | |
| K002908 | Jet Therapy | Jet Therapy | ISA | Class I | |
| K012728 | E-Scan MRI System | Esaote North America, Inc | MOS | Class II | |
| K012561 | Vitros Immunodiagnostic Products Anti-HCV Controls | Ortho-Clinical Diagnostics, Inc. | JJX | Class I | |
| K012513 | Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642 | Bio-Rad | JJY | Class I | |
| K012493 | Acumatch C-Series Cemented Femoral Component, Model Size 0 | Exactech, Inc. | JDI | Class II | |
| K012151 | Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K012080 | Ssd-5000 Diagnostic Ultrasound System | Aloka Co., Ltd. | IYN | Class II | |
| K011984 | Bd Vacutainer Push Button Blood Colection Set | Becton Dickinson & Co | FMI | Class II | |
| K011949 | Elk Laser Imager, Model El-Dry 4000 | Nishimoto Sangyo Co., Ltd. | LMC | Class II | |
| K011703 | Lumenis Versapulse Powersuite Holmium (Ho:yag) and Dual Wavelength (Ho:yag/nd:yag) Surgical Lasers and Delivery Devices | Lumenis Ltd | GEX | Class II | |
| K011694 | Viewstation | Elekta Limited | LLZ | Class II | |
| K003555 | Solo-Safe Safety Syringe, Size-3Cc | Spectrum Biotech, Inc. | MEG | Class II | |
| K003198 | Vulcan Tac Probes, Model 911Xxx | Oratec Interventions, Inc. | HRX | Class II | |
| K012431 | Combitrol Ts Multi Analyte Control, Levels 1,2,3, Autotrol Ts Multi Analyte Control, Levels 1,2,3 | Bionostics, Inc. | JJY | Class I | |
| K012284 | Wh Accu Test Pregnancy Test | W.H.P.M., Inc. | JHI | Class II | |
| K012225 | Attain 6215 Venogram Balloon Catheter | Medtronic, Inc. | DYG | Class II | |
| K012130 | Attain Lds 6216 Left-Heart Delivery System | Medtronic, Inc. | DQY | Class II | |
| K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | Medtronic, Inc. | DQY | Class II | |
| K012044 | Bi-Phasic Infiltrator | Reliance Medical Corp. | FRN | Class II | |
| K011937 | Truline Infusion Catheters | Medtronic, Inc. | FOZ | Class II | |
| K011905 | Sniper Elite Model-or-E3872xx Series | Maxxim Medical | DQX | Class II | |
| K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products, Inc. | CAW | Class II | |
| K011827 | Ortelius 800 | Orthoscan, Inc. | KQX | Class I | |
| K010203 | Accu-Pulse TENS Unit | Sadler Electronics | GZJ | Class II | |
| K002172 | Poly-Tapes (Various Sizes and Woven Construction Variants) | Xiros Ltd | GAT | Class II | |
| K012754 | Ez Set Infusion Set | Animas Corp. | FPA | Class II | |
| K012646 | Terumo 30 Gauge Hypodermic Needle | Terumo Medical Corp. | FMI | Class II | |
| K012430 | Multi-Meter Glucose Calibration Verification Material, Model RNA Gl3 | Bionostics, Inc. | JJX | Class I | |
| K012321 | Point 4 Flowable | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K012220 | Tao Embryo Transfer Catheter System | Ttj Biomedical, LLC | MQF | Class II | |
| K012203 | Clay-Park Labs, Inc. - Lubricating Jelly | Clay-Park Labs, Inc. | NUC | Class II | |
| K012174 | Eris Layering Materials | Ivoclar North America, Inc. | EIH | Class II | |
| K012110 | Dri Ecstasy Enzyme Immunoassay | Microgenics Corporation | DKZ | Class II |