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 |
|---|---|---|---|---|---|
| K993564 | Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002 | Possis Medical, Inc. | MCW | Class II | |
| K993149 | Peritoneal Dialysis Catheters and Adapters | Medionics International, Inc. | FJS | Class II | |
| K001279 | Gt990402 Digital Thermometer | Global Treasure, Ltd. | FLL | Class II | |
| K001270 | Gyrus Endourology System: Axipolar Resectoscope Loop Electrode | Gyrus ACMI, Inc. | FJL | Class II | |
| K001216 | Powder-Free Latex Examination Glove Sterile with Optional Protein Labeling Claim (50 Micrograms or Less) | Fitco Dipped Products Pvt., Ltd. | LYY | Class I | |
| K001136 | Cordis Introducer Guide | Cordis US Corp. | DQY | Class II | |
| K001094 | Safe Touch Natural Rubber Powdered Latex Examination Gloves | Jb Star Sdn Bhd | LYY | Class I | |
| K001051 | Rx Everest | Jeneric/Pentron, Inc. | EJT | Class II | |
| K001047 | Guthrie Latex Surgical Glove (Pre-Powdered) | Guthrie Medicare Products (Melaka) Sdn Bhd | KGO | Class I | |
| K001020 | 8100 Vital Signs Monitor | Criticare Systems, Inc. | MWI | Class II | |
| K000954 | Kerr Gel Etchant | Sybron Dental Specialties, Inc. | KLE | Class II | |
| K000891 | Sterile Latex Powdered Patient Examination Gloves | Fitco Dipped Products Pvt., Ltd. | LYY | Class I | |
| K000689 | Uniglove Nitrile Powder-Free Examination Gloves | N.S. Uni-Gloves Sdn. Bhd. | LZA | Class I | |
| K000684 | Small Fragment Dynamic Compression Locking (Dcl) System | Synthes (USA) Products LLC | KTT | Class II | |
| K000668 | Powder-Free Non-Vhlorinated Polymer Coated Latex Examination Gloves Contains 100 Micrograms or Less of Total Water Extra | Protection Gloves Sdn. Bhd. | LYY | Class I | |
| K000667 | Powder-Free Latex Examination Gloves with Protein Label Claim Contains 50 Micrograms or Less of Total Water Label Claim | Protection Gloves Sdn. Bhd. | LYY | Class I | |
| K000542 | Plain and Chronic Gut Absorbable Surgical Sutures, Usp | Arc Medical Supplies (Beijing) Co, Ltd. | GAL | Class II | |
| K000541 | Silk Nonabsorbable Surgical Sutures, Usp | Arc Medical Supplies (Beijing) Co, Ltd. | GAP | Class II | |
| K000445 | Medtronic Model 7499 Extension | Medtronic, Inc. | GZB | Class II | |
| K000428 | Dixi 2 | Planmeca Oy | EHD | Class II | |
| K000385 | Opti-Free Express Lens Drops | Alcon Universal, Ltd. | MRC | Class II | |
| K000357 | Ez Connect Resin | Kerr Dental Materials Center | EBF | Class II | |
| K000299 | Dermapik II Skin Test System, Dermapik II (Single Test Device), Polypik II (Multiple Skin Test Device), Dermapik Tray, D | Biomedex, Inc. | SCL | Class II | |
| DEN000006 | Eros-Clitoral Therapy Device (Ctd) | Urometrics, Inc. | NBV | Class II | |
| K994171 | Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy Cannulae | Medtronic Cardiac Surgical Products | DWF | Class II | |
| K001138 | Affinity 20 Micron Arterial Blood Filter with Carmeda Bioactive Surface, Models Cb353/cb354 | Medtronic, Inc. | DTM | Class II | |
| K001048 | Light Bond (Quick Cure) | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K001019 | Ti500 Globe-Trotter Transport System | Hill-Rom Air-Shields | FPL | Class II | |
| K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K001010 | Ascent Knee Revision Femoral Stem | Zimmer GmbH | JWH | Class II | |
| K001006 | Theratron 780C/1000 with Computerized Console Upgrade | Mds Nordion | IWB | Class II | |
| K000942 | Cadd Checkvalve Administration Set, Model 21-7090 | Sims Deltec, Inc. | FPA | Class II | |
| K000832 | Sterotactic Localization Device (Sld) | Philips North America LLC | LNH | Class II | |
| K000712 | Portable Intensive Care Unit, Model Pic | Medical Research Laboratories, Inc. | CCK | Class II | |
| K000701 | Human Igg Subclass Kit Use with the Beckman Image Analyzer | The Binding Site | CFN | Class II | |
| K000540 | Polyester Nonabsorbable Surgical Sutures, Usp | Arc Medical Supplies (Beijing) Co, Ltd. | GAT | Class II | |
| K000539 | Nylon Nonabsorbable Surgical Sutures, Usp | Arc Medical Supplies (Beijing) Co, Ltd. | GAR | Class II | |
| K000537 | Polypropylene Nonabsorbable Surgical Sutures, Usp | Arc Medical Supplies (Beijing) Co, Ltd. | GAW | Class II | |
| K000227 | Umbicut | Pollak (Intl.).ltd | HFW | Class II | |
| K993630 | Biolok Screw | Encore Orthopedics, Inc. | HWC | Class II | |
| K993513 | Deltaloc Anterior Cervical Plate System | Alphatec Spine, Inc. | KWQ | Class II | |
| K991549 | Embosphere Microspheres | Biosphere Medical, S.A. | HCG | Class II | |
| K000920 | Reaads Iga Anti-Phosphatidylserine Semi-Quantitative Test Kit | Corgenix, Inc. | MID | Class II | |
| K000361 | K-Assay at-III | Kamiya Biomedical Company, LLC | JBQ | Class II | |
| K000338 | Vitaport 3 | Nihon Kohden America Inc | OLV | Class II | |
| K000096 | Ontrak Teststik for Methamphetamine, Cat. 1986686 | Roche Diagnostics GmbH | LAF | Class II | |
| K994023 | Haemacure Hemamyst Surgical Applicator System H-As01 | Haemacure Corp. | FMF | Class II | |
| K993410 | Dates-Ohmeda Aestiva Smartvent MRI | GE Healthcare | BSZ | Class II | |
| K001118 | Modification to Lipoprotein (a) Spq III Antibody Reagent Set | Diasorin Inc. | DFC | Class II | |
| K001021 | Lilliput Phospholypidic Inert Surface in Oxygenation (Ph.i.s.i.o.) Infant Hollow Fibre Oxygenator, Model D902 | Dideco S.p.A. | DTZ | Class II |