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 |
|---|---|---|---|---|---|
| K993324 | Carbocem Zinc Polycarboxylate Cement | Scientific Pharmaceuticals, Inc. | EMA | Class II | |
| K993281 | K-Assay Igg | Kamiya Biomedical Company, LLC | DEW | Class II | |
| K993219 | Wako Bilirubin Calibrator | FUJIFILM Healthcare Americas Corporation | JIS | Class II | |
| K993174 | Sysmex Automated Coagulation Analyzer, Model Ca-6000 | Siemens Healthcare Diagnostics Inc. | GKP | Class II | |
| K993161 | Copan Easy-Swab Collection and Transport System | COPAN Diagnostics, Inc. | JTW | Class I | |
| K993050 | Omni Grace Nitrile, Green, Examination Glove, Powder-Free, Polymer Coated | Omnigrace, Ltd. | LZA | Class I | |
| K993022 | Synchron Systems Op 300 Low and High Urine Calibrators | Siemens Healthcare Diagnostics Inc. | DLJ | Class II | |
| K992997 | Osteomark Ntx Poc | Metrika, Inc. | JMM | Class I | |
| K992886 | Powerview Ultrasound Workstation, Uidm-400A | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K992879 | Ecusit Composite Repair | Dmg Hamburg | KLE | Class II | |
| K992875 | Sysmex Xe-2100, Automatated Hematology Analyzer | Sysmex Corporation | GKZ | Class II | |
| K992836 | Sl990, Sl980, Sl950 | Cso | HJO | Class II | |
| K992794 | Stingray Dr, Model 1 | Infimed, Inc. | MQB | Class II | |
| K992746 | Signa Hfo/i Magnetic Resonance System | GE Healthcare | LNH | Class II | |
| K992741 | Lyphochek Anemia Control, Model 500 | Bio-Rad | JJY | Class I | |
| K992740 | Ebt Ultrafast CT Scanner System; Ultrafast CT Scanner System; C-100, C-150, C-150Lxp or C-150Xp Scanner Systems | Imatron, Inc. | JAK | Class II | |
| K992709 | 1818 TENS Unit | 138 Medical Supplies, Inc. | GZJ | Class II | |
| K992136 | Bayer Advia Integrated Modular System (Ims) | Bayer Corp. | CIT | Class II | |
| K991907 | Additional Ims Assays for the Bayer Advia Ims System | Bayer Corp. | CZW | Class II | |
| K991880 | Light Diagnostics Simulfluor Hsv 1/2 Immunofluorecence Assay | Light Diagnostics | GQN | Class II | |
| K990457 | Ted 60T Oxygen Analyzer | Teledyne Electronic Technologies | CCL | Class II | |
| K993516 | Hp M2600a Viridia Telemetry System | Hewlett-Packard Co. | DSI | Class II | |
| K993242 | Castle Surgical Light, Model 3000 | Getinge/Castle, Inc. | FSY | Class II | |
| K993146 | Dornier Scanner Handpiece | Dornier Surgical Products, Inc. | GEX | Class II | |
| K993141 | At Home Quickcup Pregnancy Test, Model 9015 | Phamatech Inc. | LCX | Class II | |
| K992970 | Digit Widget | Hand Biomechanics Lab Inc | JDW | Class II | |
| K992961 | Lorenz Small Fragment System | Biomet Microfixation | HRS | Class II | |
| K992738 | Isobar Spinal System | Encore Orthopedics, Inc. | MNI | Class II | |
| K992702 | Event Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow Encasing, Event Bedding System | Allergy Direct | FMW | Class I | |
| K992674 | Hp Viridia Cms Patient Monitor with EEG Parameter, Model M1027a | Hewlett-Packard Co. | MHX | Class II | |
| K992621 | Adi 9000/9001 Arthroscope and Accessories | Advanced Diagnostics & Interventions | HRX | Class II | |
| K991662 | Titanium Hartshill System | Surgicraft, Ltd. | KWP | Class II | |
| K991326 | Isobar Semi-Rigid Spinal System | Scien'Tx USA, Inc. | MNI | Class II | |
| K993459 | Modification to Brennen Biosynthetic Surgical Mesh Matrix | Advanced Uroscience, Inc. | PAG | Class II | |
| K993398 | Echo View, Easy View, Omni View | TOMTEC Imaging Systems GmbH | IYO | Class II | |
| K993394 | Echo Scan, Easy Scan | TOMTEC Imaging Systems GmbH | IYO | Class II | |
| K993365 | Ge Logiq 700 with Harmonic Imaging Modification | GE Healthcare | IYO | Class II | |
| K993364 | Ge Logiq 700 with Coded Excitation Modification | GE Healthcare | IYO | Class II | |
| K993325 | Innovative Gloves, Nitrile Butadiene Rubber Powder-Free | Innovative Gloves Co;, Ltd. | LZA | Class I | |
| K993300 | Coldlightsource Pl3000 | Fiber Imaging Technologies, Inc. | FCW | Class II | |
| K993247 | Nitrile Powder Free Patient Examination Gloves | Jda Intl., Inc. | LZA | Class I | |
| K993222 | Innovative Gloves, Latex Examination Gloves Powderfree | Innovative Gloves Co;, Ltd. | LYY | Class I | |
| K993221 | Innovative Gloves, Latex Examination Gloves, Prepowdered | Innovative Gloves Co;, Ltd. | LYY | Class I | |
| K993187 | Shelly Protected Av Fistula Needle | Diasol, Inc | FPA | Class II | |
| K993032 | Modification to Mp-3 Power Base Chair | Merits Health Products, Inc. | ITI | Class II | |
| K992999 | Daisy Protected Scalp Vein Set | Diasol, Inc | FPA | Class II | |
| K992924 | Qtexx, Non-Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-Coated | Latexx Partners Bhd. | LZA | Class I | |
| K992817 | Antibacterial Adhesive Bandage | William Feinstein & Associates, Inc. | FRO | Unclassified | |
| K992797 | Synthetic Powdered Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | LYZ | Class I | |
| K992752 | Surgeon's Gloves Pre-Powdered, Models 6.5, 7, 7.5, 8, 8.5 | P.T. Maja Agung Latexindo | KGO | Class I |