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 |
|---|---|---|---|---|---|
| K002023 | Medmira Rapid H. Pylori Antibody Test, Model 10714 | Medmira Laboratories, Inc. | LYR | Class I | |
| K001993 | Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision Control Solutions | Abbott Medical | LFR | Class II | |
| K001440 | Nextstitch Cardiovascular Valve Suture | Genzyme Surgical Product (Genzyme Biosurgery) | GAT | Class II | |
| K001177 | Pp-Cap Eia for the Detection of Iga Antibodies to H. Pylori | Enteric Products, Inc. | LYR | Class I | |
| K003179 | Siemens Multiview Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K002805 | Kendro Heracell CO2 Incubator | Kendro Laboratory Products, L.P. | MQG | Class II | |
| K002720 | Formula One Sterile Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less) Made from Allo | Tillotson Healthcare Corp. | LYY | Class I | |
| K002693 | Cbw Bridge System (Consisting of Cbw Andchors, Cbw Micro-Handpiece and Burs) | Cbs Intl. B.V. | EBL | Class I | |
| K002687 | Zynergy Z4 Transvenous Bipolar Pacing Catheter, Model 04-X-02-3-10-3 | Zynergy Cardiovascular, Inc. | LDF | Class II | |
| K002503 | Fetalgard Lite | Analogic Corp. | HGM | Class II | |
| K002486 | Precimed Trauma System | Patrick Berdoz | HRS | Class II | |
| K002476 | Lumboperitoneal Shunt System | Phoenix Biomedical Corp. | JXG | Class II | |
| K002475 | Replace Tps Coated Implants | Nobel Biocare Uas, Inc. | DZE | Class II | |
| K002357 | 100 S and 100 Lc and 485 Anser Ultrasound Imaging Systems | Pie Medical | IYO | Class II | |
| K002062 | Samsung 10Dr Implant System | Samsung Sds Co., Ltd. | EHD | Class II | |
| K003340 | Obc-149 Breast Array Coil | Mri Devices Corp. | MOS | Class II | |
| K003331 | Qwh-149 Wrist Array Coil | Mri Devices Corp. | MOS | Class II | |
| K003315 | Shiley Tracheosoft Xlt Extended Length Tracheostomy Tube and Disposable Inner Cannula | Mallinckrodt, Inc. | JOH | Class II | |
| K003256 | Pccr Digital Imaging Device | Orex Computed Radiography, Ltd. | MQB | Class II | |
| K003244 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K003220 | Personal ECG Transmitter, Model Cg-6550 | Card Guard Scientific Survival, Ltd. | DXH | Class II | |
| K003167 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K002966 | Ocu-Flex-49 Spherical, Toric, Aspherical and Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily Wear | Ocu-Ease Optical Products, Inc. | LPL | Class II | |
| K002812 | Iris Retracting Phacoemulsification Sleeve | Michael Reynard, M.D. | HQC | Class II | |
| K002792 | Careside Cholinesterase | Careside, Inc. | DIH | Class I | |
| K002707 | Pvs 1400 Guide Wite with Hydrophilic Coating | Precision Vascular Systems, Inc. | DQX | Class II | |
| K002640 | Freedom Automatic Film Processor | J. Morita USA, Inc. | IXW | Class II | |
| K002502 | Ceram-Prime | S & C Polymer GmbH | KLE | Class II | |
| K002499 | Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and 3-Liter Calibration Syringe | Brentwood Medical Technology Corp. | BZG | Class II | |
| K002473 | Wec-7101A Pocket Size ECG Monitor and Accessories | Nihon Kohden America Inc | DPS | Class II | |
| K002463 | Stellar | Skytron, LLC | FSY | Class II | |
| K002459 | Pagewriter 10/10I, Model M2662a Handheld Electrocardiograph | Agilent Technologies, Inc. | DPS | Class II | |
| K002139 | Etest Linezolid | Ab Biodisk | LTX | Class II | |
| K003208 | R & D 3K Retic | R & D Systems, Inc. | JPK | Class II | |
| K003204 | Bartels Viral Respiratory Screening and Identification Kit | Intracel Corp. | GNW | Class I | |
| K003193 | Duplogrip | Baxter Healthcare Corporation | FMF | Class II | |
| K003181 | Implex Continuum Hip System Acetabular Components - Model Xx-Yyy-Zzzz | Implex Corp. | LPH | Class II | |
| K003133 | Multiple-Vinyl Exam Glove, Powdered | Excellence Ent. Co., Ltd. | LYZ | Class I | |
| K003087 | Modification to Sporicidin Sterilizing and Disinfecting Solution | Sporicidin Intl. | MED | Class II | |
| K003070 | Ethibond Excel Valve Loop Suture | Ethicon, Inc | DXZ | Class II | |
| K001433 | Cns-9300 Series Central Station | Nihon Kohden America Inc | MHX | Class II | |
| K000870 | Km-10 TENS Electrode | Katecho LLC | GXY | Class II | |
| K992493 | Vipon Tampon | Another Way Products, LLC | HEB | Class II | |
| K003296 | Biomet Sck Knee System | Zimmer GmbH | JWH | Class II | |
| K003287 | Model K7 Evaluation Device | Myotronics-Noromed, Inc. | KZM | Class II | |
| K003235 | Pe.r.i. II Knee Fracture System | Depuy Orthopaedics Inc. | HRS | Class II | |
| K002990 | Vti Adult Disposable Skull Pin, Model 22000; Vti Skull Screw, Model 22001 | Vascular Technology Incorporated | HBL | Class II | |
| K002904 | Willi Geller Creation and Lf Porcelain | Jensen Industries, Inc. | EIH | Class II | |
| K000023 | Friendly Light Er:yag Pulsed Laser | Innotech USA, Inc. | GEX | Class II | |
| K003294 | Biomet Lateral Troch Plate | Zimmer GmbH | JDW | Class II |