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 |
|---|---|---|---|---|---|
| K020226 | Xenostrip-Tv Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 & S1383.03 | Hellen Professional Services | JWZ | Class I | |
| K013532 | Ultrastim Kit | Axelgaard Mfg. Co., Ltd. | GZJ | Class II | |
| K013051 | Nanma Adjustable Constriction Ring | Nanma Mfg Co., Ltd. | LKY | Class II | |
| K022605 | Blackstone Spinal Fixation System Staple & Washer | Blackstone Medical, Inc. | KWQ | Class II | |
| K022603 | Immulite 1000 Automated Immunoassay Analyzer | Siemens Healthcare Diagnostics Inc. | CEW | Class II | |
| K022575 | Perfusor Compact with Fm System | B.Braun Medical, Inc. | FRN | Class II | |
| K022544 | Dornier Medilas H Laser Fiber Cables | Dornier Medtech America, Inc. | GEX | Class II | |
| K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | DSI | Class II | |
| K022401 | Pts Panels Multi-Chemistry Controls | Polymer Technology Systems | JJY | Class I | |
| K022150 | Trionomer | Pentron Clinical Technologies | EMA | Class II | |
| K021972 | Fastpack Total Testosterone Immunoassay | Qualigen Inc | CDZ | Class I | |
| K021528 | Reprocessed Venodyne Sequential Compression Sleeves / Wrap | Adven Medical | JOW | Class II | |
| K021315 | Sure-Lok | Vital Signs, Inc. | FMI | Class II | |
| K013046 | Cosmos System | GE Healthcare | DSI | Class II | |
| K022553 | Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4L | Integra NeuroSciences | GWM | Class II | |
| K022542 | Philips Baby Thermometer Set (Sbc Sc530) | Philips Consumer Electronics | FLL | Class II | |
| K022410 | Saph-Loop Ligating Loop | Genzyme Biosurgery | GAT | Class II | |
| K022184 | Flash-Lite LED Dental Curing Light | Discus Dental LLC | EBZ | Class II | |
| K021745 | Vasclip | Vmbc, LLC | NJC | Class II | |
| K021717 | Endoscopic Light Source, Model Xl300/l5 | World of Medicine Lemke GmbH | GCT | Class II | |
| K021696 | 20G Sma Laser Fiber, Model Lf20; 25G Sma Laser Fiber, Model Lf25 | Ophthalmed LLC | GEX | Class II | |
| K021686 | Laser Fiber Gf500 | Novanta Medical GmbH | GEX | Class II | |
| K013759 | Mss-28Cs-301/701 Needlescope | Olympus Optical Co., Ltd. | GWG | Class II | |
| K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Medtronic, Inc. | FRG | Class II | |
| DEN020003 | Retrox | Auric Hearing Systems, Inc. | NIX | Class II | |
| K022460 | Smith & Nephew Image Guided Surgical System for Knee Applications | Smith & Nephew, Inc. | HAW | Class II | |
| K022010 | Total Knee Femoral Component | Smith & Nephew, Inc. | JWH | Class II | |
| K021805 | Seal & Protect Protective Sealant | Dentsply Intl. | LBH | Class II | |
| K021738 | Flat Panel Displays, Me Series & Ccl Series | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K021724 | Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems | Dornier Medtech America, Inc. | GEX | Class II | |
| K013958 | Indus Textiles Towel-Sterile and Non-Sterile | Indus Textiles, Inc. | KKX | Class II | |
| K022463 | Ha Modular Reach Proximal Porous and Ha Modular Reach Collared Proximal Porous Femoral Stems | Biomet Orthopedics, Inc. | LPH | Class II | |
| K022407 | Multi Fuctional Rehabilitation Chair | Raye'S, Inc. | INO | Class II | |
| K021960 | Precision Point of Care Blood Glucose Test Strip with True Measure Technology | Abbott Medical | LFR | Class II | |
| K021765 | Cement Restrictor, Small and Large | Exactech, Inc. | JDK | Class II | |
| K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | Quantel Medical | GEX | Class II | |
| K014210 | Palmo Thermoregulation Interface Accessory | Avacore Technologies, Inc. | DWJ | Class II | |
| K013623 | Clearlight Phototheraphy System, Model Cl 420 | Curelight, Ltd. | GEX | Class II | |
| K011700 | Modulith Slk Lithotripter | Karl Storz Endoscopy-America, Inc. | LNS | Class II | |
| K022586 | Anterior Stabilized Tibial Bearings | Biomet Orthopedics, Inc. | JWH | Class II | |
| K022548 | Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves | Latexx Manufacturing Sdn.Bhd. | LZA | Class I | |
| K022529 | Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3, Models 667,668,669 | Bio-Rad | JJS | Class I | |
| K022525 | Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3, Model 507, 508, 509 | Bio-Rad | JJS | Class I | |
| K022348 | Access Concentration System, Model Acc-100, Access Disposable Set, Model Ads-2000 | Interpore Cross Intl. | CAC | Class II | |
| K022347 | Medtexx Green Colour Powdered Nitrile Rubber Examination Gloves | Latexx Manufacturing Sdn.Bhd. | LZA | Class I | |
| K022345 | Autopulse Resuscitation System | Revivant Corp. | DRM | Class II | |
| K022333 | Spife Lipporotein-12, Model 3344 | Helena Laboratories, Corp. | JHO | Class I | |
| K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | IYO | Class II | |
| K022045 | Vitek Gram Positive Susceptibility (Gps) Card for Linezolid | bioMerieux, Inc. | LON | Class II | |
| K022025 | Modification to Potassium Nitrate-Polycarboxylate Dental Cement | Milton Hodosh, M.D. | EJK | Class II |