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 |
|---|---|---|---|---|---|
| K003626 | Devilbiss Humidifier | Sunrise Medical Hhg, Inc. | BTT | Class II | |
| K003442 | Modification to Edi Veris System | Electro-Diagnostic Imaging, Inc. | HLX | Class II | |
| K003123 | Renax A.v. Fistula Needle Sets | Sunder Biomedical Tech. Co., Ltd. | FIE | Class II | |
| K002801 | Mps M Electrode | Medical Physics and Services, Inc. | LNS | Class II | |
| K002763 | Remrest | Medical Industries America, Inc. | BZD | Class II | |
| K002193 | Tetrad Tc-C3-Acp | Tetrad Corp. | ITX | Class II | |
| K011157 | Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit | Cook Incorporated | MQL | Class II | |
| K010991 | Seednet, Models Fp6t5, Fp5t5, Fp5t3 | Galil Medical Ltd. | GEH | Class II | |
| K010867 | Kilejian Circumcisor | Iris Surgical, LLC | HFX | Class II | |
| K010863 | Laglove Brand Nitroprene Powder Free Examination Gloves (Made of Nitrile-Neoprene Co-Polymer) | La Glove (M) Sdn. Bhd. | LZA | Class I | |
| K010695 | Koala Clamp | Maternus, Inc. | HFW | Class II | |
| K010661 | Modification to Tissuelink Bipolar Forceps | Medtronic Navigation, Inc | GEI | Class II | |
| K010638 | Neuroplus, Model A10040, A10041, A10042, A10043 | Vermont Medical, Inc. | GXY | Class II | |
| K010499 | Synthes (USA) Midface Distractor | Synthes (USA) Products LLC | JEY | Class II | |
| K010487 | Bipolar Pencil, Model 3901-002, 3900-002 | Medtronic PS Medical | GEI | Class II | |
| K010483 | Powderfree Colored Latex Examination Gloves (Pink, Blue, Green, and White) with Protein Content Labeling Claim (50 Micr0 | PT. Medisafe Technologies | LYY | Class I | |
| K010348 | Tantalum Beads - Radiographic Marker | Zimmer GmbH | NEU | Class II | |
| K010344 | Adjustable Large Fixator System | Synthes (USA) Products LLC | KTT | Class II | |
| K003528 | Sanarus Core Tissue Biopsy System | Varian Medical Systems, Inc. | KNW | Class II | |
| K003458 | Soft Beat Fetal Heart Rate Electrode Model Sbt-7000 | Clinical Innovations, LLC | HGP | Class II | |
| K002565 | Baylis Pain Management Generator Model: Pmg-115 (for Domestic Use), Pmg-230 (for International Use) | Baylis Medical Co., Inc. | GXD | Class II | |
| K002256 | Arrow Acat 2 Intra-Aortic Balloon Pump | Arrow Intl., Inc. | DSP | Class II | |
| K001807 | Tissue Marker | Advanced Uroscience, Inc. | GDW | Class II | |
| K011162 | Modification to the Emit II Plus Cocaine Metabolite Assay | Syva Co., Dade Behring, Inc. | DIO | Class II | |
| K011126 | Raichem Creatinine Urine Standard | Hemagen Diagnostics, Inc. | JIT | Class II | |
| K011115 | Kurz Upper Eyelid Implant- Platinum/iridium,models Regular 4007 003-007, Special 4007 002, 4007 008-010 | Heinz Kurz GmbH Medizintechnik | MML | Class II | |
| K011088 | Siii Alarm Amplifier | Stockert Instrumente GmbH | DTQ | Class II | |
| K011023 | D.sign 96 | Ivoclar North America, Inc. | EJT | Class II | |
| K011022 | Biouniversal Pdf | Ivoclar North America, Inc. | EJT | Class II | |
| K011009 | White Mta Material | Dentsply International, Inc. | KIF | Class II | |
| K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | IYE | Class II | |
| K010346 | Ksea Sawahle Electromechanical Morcellator | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | HSB | Class II | |
| K010321 | Modular Foot System - 2.7 Mm Module | Synthes (USA) Products LLC | KTW | Class II | |
| K010305 | Weiss Retinal Cannula | Micron Surgical, Inc. | HMX | Class I | |
| K010244 | Sure Check Ovulation Predictor | Chembio Diagnostic Systems, Inc. | CEP | Class I | |
| K010183 | Global by <Genx> Blastocyst Media | <Genx> Intl., Inc. | MQL | Class II | |
| K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870a | Agilent Technologies, Inc. | MKJ | Class III | |
| K003320 | Pta-Os Sizing Balloon, Model 360 | Numed Inc | MJN | Class II | |
| K002817 | Synetec | Ela Medical, Inc. | DQK | Class II | |
| K002334 | Macroporens Craniloc | Macropore Biosurgery, Inc. | GXR | Class II | |
| K002186 | Vascular Assist | Huntleigh Healthcare Ltd. | DPW | Class II | |
| K011096 | Abbott Acclaim Encore, Model 12237 | Abbott Medical | FRN | Class II | |
| K011093 | Agilent Information Center Software for M3150,m3151,m3153 and M3154 | Agilent Technologies, Inc. | MHX | Class II | |
| K011012 | Powder Free Nitrile Examination Glove | Contract Latex Dippers Sdn Bhd | LZA | Class I | |
| K010494 | Sysmex Automated Coagulation Analyzer, Model Ca-1500 | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K010439 | Maxitex Duplex Sterile Latex Powdered Surgeon Gloves with Protein Labeling Claim (100 Micrograms or Less) | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K010438 | Maxitex Duplex Powder Free Latex Sterile Surgeon Gloves Protein Labeling Claim (50 Micrgrams or Less) | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K010316 | Cooltouch Varia Nd:yag Laser System; Cooltouch Varia-II Nd:yag Laser System | Cooltouch Corp. | GEX | Class II | |
| K010292 | Drx 2000 | Axiom Worldwide, Inc. | ITH | Class II |