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 |
|---|---|---|---|---|---|
| K020655 | Deltec Insulin Infusion Pump and Accessories | Abbott Medical | LZG | Class II | |
| K013828 | Glovco Ebony | Glovco (M) Sdn. Bhd. | LYY | Class I | |
| K013691 | Ceralas D Diode Laser System, Model # D50 | Biolitec, Inc. | GEX | Class II | |
| K012708 | Electrophysiology Catheter | Alliance Medical Corp. | NLH | Class II | |
| K022546 | Horizons Anso Transbronchial Aspiration Needles | Horizons Intl. Corp. | EOQ | Class II | |
| K022523 | Rapid-Fill Tubeset, Model 90005 | Baxa Corp. | LHI | Class II | |
| K022419 | Ebi Spinelink Anterior Cervical Spinal System | Ebi, LLC | KWQ | Class II | |
| K022405 | Modification to Promax-Xp, TENS and Microcurrent Device; Promax-TENS, TENS Device; Promax-Libra, TENS Device; Promax-Mic | Rehabilicare, Inc. | GZJ | Class II | |
| K022319 | Ebi Xfix Dfs System | Ebi, LLC | KTT | Class II | |
| K022233 | Hydroboot | Incappe, Inc. | DWL | Class II | |
| K022218 | Cadence Cement Restrictor | Spinal Concepts, Inc. | JDK | Class II | |
| K022172 | Bd Phoenix Automated Microbiology System | Becton Dickinson & Co | LON | Class II | |
| K022002 | Sydney Ivf Culture Oil | Cook Incorporated | MQL | Class II | |
| K021964 | Alpha Infusion Pump and Catheters | Advanced Infusion, Inc. | MEB | Class II | |
| K021949 | Fulcrum | Howtek, Inc. | LMA | Class II | |
| K021934 | Modification to Medstation | Aisoftw@Re Medical, S.p.A. | LLZ | Class II | |
| K021902 | Magellan Autologus Platelet Separator, Mag100, Magellan Autologous Platelet Separator Deisposable Kit, Mkt300 | Medtronic, Inc. | JQC | Class I | |
| K021749 | Ebi Dynafix Vs Osteotomy System | Ebi, LLC | NDF | Class II | |
| K021720 | Multivision Methafilcon a Soft (Hydropilic) Multifocal Lens for Daily Wear | Soflex Isralens Contact Lens, Ltd. | LPL | Class II | |
| K021668 | Nitrile Examination Gloves Powderfree (Blue Color) | Innovative Gloves Co;, Ltd. | LZA | Class I | |
| K021662 | Magly 6.5Mm Cannulated Screws | Magly Orthopedics, LLC | HWC | Class II | |
| K021659 | Pre-Powdered Latex Examination Gloves with Protein Labeling Claim (180 Ug/or Less) | P.T. Healthcare Glovindo | LYY | Class I | |
| K021657 | Uknee Total Knee System | United Orthopedic Corp. | JWH | Class II | |
| K021626 | Hallu Plates | New Deal, S.A. | HRS | Class II | |
| K021583 | Patxfer | Brainlab, Inc. | LLZ | Class II | |
| K021574 | Tm2000 Fetaltrace Transtelephonic Receiving Center | Card Guard Scientific Survival, Ltd. | HGM | Class II | |
| K021571 | Transonic Flow-Qc Set Model Adt1010 | Transonic Systems Inc | MQS | Class II | |
| K003128 | Modification to Relief Brief | The JM Kohn Co. | NJB | Class I | |
| K022362 | Given Diagnostics System | Given Imaging Ltd. | NEZ | Class II | |
| K022095 | Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove | Wilshire Technologies | LZA | Class I | |
| K021579 | Magly 4.0 and 5.5 Mm Locking System | Magly Orthopedics, LLC | HWC | Class II | |
| K021578 | Natural-Knee II System Cocr Tibial Baseplate | Sulzer Orthopedics, Inc. | JWH | Class II | |
| K021556 | Synthes 2.4 Mm Cannulated Compression Screw | Synthes (USA) Products LLC | HWC | Class II | |
| K021550 | Lumenis Selecta Duet | Ellex Medical Pty Ltd | GEX | Class II | |
| K010727 | Flexline Clamp | Novare Surgical Systems, Inc. | DXC | Class II | |
| K022426 | Bd Preset Blood Collection Syringe, Bd a-Line Blood Collection Syringe, Models 365313, 365323,365316,365356,365373,36538 | Becton Dickinson & Co | JKA | Class II | |
| K022404 | Actiband | Paw, LLC | ILX | Class II | |
| K022305 | Multiple Labels, Powder-Free Poly-Vinyl Exam Gloves, Color: White | Heyuan Hongli Industries, Inc. | LYZ | Class I | |
| K022223 | Aart Silicone Sheeting | Aesthetic and Reconstructive Technologies, Inc. | MIB | Class II | |
| K022222 | Lamitrode S-Series (S4 and S8) Leads | Advanced Neuromodulation System,Inc | GZB | Class II | |
| K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | DRN | Class II | |
| K021735 | Boston Scientific Ultra-Soft Sv Balloon Dilatation Catheter | Boston Scientific Corporation | DQY | Class II | |
| K021731 | Adapt Open Access Port, Model 41233 | Taut, Inc. | GCJ | Class II | |
| K021723 | Sheath Adapter, Model Sa-09847 | Arrow Intl., Inc. | DYB | Class II | |
| K021618 | Osa Rigid Internal Fixation System | Osteomed | JEY | Class II | |
| K021538 | Lightlas 810 Infrared Laser Photocoagulator | Lightmed Corp. | HQF | Class II | |
| K021143 | Opti-Free Express Multi-Purpose Disinfecting Solution | Alcon Universal, Ltd. | LPN | Class II | |
| K021064 | Quantim 16 Autoclave | Scican Ltd. | FLE | Class II | |
| K020833 | Boyd Delivery Unit | Boyd Industries, Inc. | EIA | Class I | |
| K013784 | Ureteral Stent | Boston Scientific Corporation | FAD | Class II |