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 |
|---|---|---|---|---|---|
| K011554 | Lorenz Lactosorb Vocal Medialization Implant | Zimmer GmbH | MIX | Class II | |
| K011542 | Specialty D-UV (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty D-UV Multifocal (Ocuflicon D) | Specialty Ultravision, Inc. | LPL | Class II | |
| K011410 | Para 5X | Streck Laboratories, Inc. | JPK | Class II | |
| K011321 | Modification to Xps 3000 System | Medtronic Xomed, Inc. | ERL | Class II | |
| K011277 | Hard Reliner | S & C Polymer GmbH | EBI | Class II | |
| K011209 | Manan Spritacre Spinal Needles | Argon Medical Devices, Inc | BSP | Class II | |
| K011191 | Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic Sponges | Medtronic Xomed, Inc. | HOZ | Class II | |
| K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K003927 | Y2000 Manual Resuscitator, Model Rugu01/rug02 and Rugh01/rugh02 | Cheen Houng Ent. Co. Ltd. | BTM | Class II | |
| K011720 | Olympus Au5400 Clinical Chemistry Analyzer | OLYMPUS Corporation of the Americas | CIX | Class II | |
| K011424 | Il Test Pros | Instrumentation Laboratory Co. | GGP | Class II | |
| K011383 | Microdose Cath, Models 90121-201, -202, -203 | Durect Corp. | ETD | Class II | |
| K011348 | Phase II Gbm Igg Antibody Eia Test | Scimedx Corp. | MVJ | Class II | |
| K011245 | Advent Implant System, Swiss Plus Implant System | Sulzer Dental, Inc. | DZE | Class II | |
| K011226 | Calibrator for Automated Systems | Roche Diagnostics GmbH | JIX | Class II | |
| K011222 | Portabell, Model 4200 | Bell Dental Products, LLC | EIA | Class I | |
| K011181 | Ics Medical Chartr Oae with Tymp | Ics Medical Corp. | EWO | Class II | |
| K011145 | Modification to Reflotron Amylase, Cat. 1200658 | Roche Diagnostics GmbH | JFJ | Class II | |
| K011119 | Brachyseed Pd-103 Models #Pd1 | Draximage, Inc. | KXK | Class II | |
| K010957 | Quell Desensitizer | Jeneric/Pentron, Inc. | LBH | Class II | |
| K010937 | Sep-10S Plus, and Sp-12S Pro. | Viltechmeda | FRN | Class II | |
| K010921 | Advantage Marijuana (Thc) Home Drug Test | Advantage Diagnostics Corp. | LDJ | Class II | |
| K010703 | Inter-Vial | Duoject Medical Systems, Inc. | LHI | Class II | |
| K010334 | Wako Lipid Calibrator | FUJIFILM Healthcare Americas Corporation | JIT | Class II | |
| K010326 | Wako Autokit C3 | FUJIFILM Healthcare Americas Corporation | CZW | Class II | |
| K010325 | Wako Autokit C4 | FUJIFILM Healthcare Americas Corporation | DBI | Class II | |
| K010239 | Cocaine Dipstick Test, Model D747-a | Teco Diagnostics | DIO | Class II | |
| K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K003068 | Savina | Drager Medizintechnik GmbH | CBK | Class II | |
| K011789 | Procedure Masks: Pm4-301 and Pm4-304 | Primeline Medical Products, Inc. | FXX | Class II | |
| K011773 | Dornier Lithotripter 140(Doli 140) | Dornier | LNS | Class II | |
| K011755 | Stryker T4 Hytrel (R) Togas | Stryker Corp. | LYU | Class I | |
| K011701 | Biotech Manual Wheelchair C650 Series Tour Light Wheelchair | Taiwan Armada Enterprise Co., Ltd. | IOR | Class I | |
| K011677 | Medlite Q-Switched Nd:yag Laser Replaced by the Medlite C3 Q-Swtiched Nd:yag Laser | Continuum Electro-Optics, Inc. | GEX | Class II | |
| K011675 | The Autotac System | BioHorizons Implant Systems Inc | DZL | Class II | |
| K011612 | Modification to Hydrocision Debridement System | Hydrocision, Inc. | FQH | Class II | |
| K011584 | Medtronic Spinal Cord Stimulation and Peripheral Nerve Stimulation Systems for Pain Relief | Medtronic, Inc. | GZB | Class II | |
| K011435 | Hmt 21, Hmt 2000 Urinary Incontinence System | Hmt, Inc. | KPI | Class II | |
| K011331 | Jp Cast 40 | Jeneric/Pentron, Inc. | EJT | Class II | |
| K011330 | Jp Cast 50 | Jeneric/Pentron, Inc. | EJT | Class II | |
| K011309 | Lute Vlc; Core Vlc | First Scientific Limited | EBF | Class II | |
| K011270 | Automated Core Biopsy Device | Promex, Inc. | FCG | Class II | |
| K011168 | Neurogen Nerve Guide | Integra LifeSciences Corporation | JXI | Class II | |
| K011018 | Taut Balloon Catheter, Model 50640 | Taut, Inc. | GCA | Class II | |
| K011015 | Catheter Repair Kit with Replacement Connector, Model 5587000 | C.R. Bard Inc | NFK | Class II | |
| K010990 | Ams Sling Fixation System | American Medical Systems, Inc. | GAW | Class II | |
| K010941 | The Nimble Rocket Powered Wheelchair | Nimble, Inc. | ITI | Class II | |
| K010920 | Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring | Medical Cables, Inc. | HEL | Class II | |
| K010872 | Ml Blade, Model Ml7030 | Med-logics Inc | HNO | Class I | |
| K010233 | Powder Free Nitrile Examination Gloves | P.T. Healthcare Glovindo | LZA | Class I |