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 |
|---|---|---|---|---|---|
| K001711 | M2410b Imagepoint Hx Multispecialty System, Version B.1 | Agilent Technologies, Inc. | IYN | Class II | |
| K001559 | Calcium Sulfate Pellets | Howmedica Osteonics Corp | MQV | Class II | |
| K001478 | Aurecast Super Inlay | Aurex SA (Pty), Ltd. | EJT | Class II | |
| K001477 | Aurelux Y 84 Premium | Aurex SA (Pty), Ltd. | EJT | Class II | |
| K001360 | Signum | J.F. Jelenko & Co., Inc. | EBF | Class II | |
| K001312 | Model 473Si-64E Quadrature Lower Extremity Coil | Igc-Medical Advances, Inc. | MOS | Class II | |
| K001311 | Synthes (USA) Oribital Mesh Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K001303 | Breast Immobilization Device Mr-by 160 | Mri Devices Corp. | MOS | Class II | |
| K001286 | Ethanol-L3k Assay, Models 273-30, 273-17, 273-10 | Sekisui Diagnostics P.E.I. Inc. | DIC | Class II | |
| K001067 | Dade Behring Coagulation Analyzer (Bct) | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K001026 | 3D-Mspect | The Reagents of the University of Michigan | KPS | Class II | |
| K994239 | Zephir Anterior Cervical Plate System | Medtronic Sofamor Danek | KWQ | Class II | |
| K001737 | Opaque Herrick Plug, 0.3Mm; 0.5Mm; O.7mm | Lacrimedics, Inc. | LZU | Unclassified | |
| K001632 | Opti-Check Plus Multi-Analyte Control, Model Hc7009 | Avl Scientific Corp. | JJY | Class I | |
| K001567 | Advantage Thc Test | Advantage Diagnostics Corp. | LDJ | Class II | |
| K001484 | Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse Solution Kit, Model A943-838 | Alko Diagnostic Corp. | JIX | Class II | |
| K000801 | Pc Coated Fluoroplastic Vent Tubes | Gyrus Ent LLC | ETD | Class II | |
| K000754 | Quantase Phenylalanine Screening Assay 500 Test Kit | Quantase, Ltd. | JNB | Class II | |
| K001592 | Echocom, Imagecom, Dokucom | TOMTEC Imaging Systems GmbH | DQK | Class II | |
| K001532 | Dyna-Lok Classic Spinal System | Medtronic Sofamor Danek | KWP | Class II | |
| K001463 | Schottlander Enigma Colour Tone, Model 0156 | Davis Schottlander & Davis, Ltd. | EBI | Class II | |
| K000996 | Trubyte Denture Cleanser/polishing Compound | Dentsply Intl. | EFT | Class I | |
| K000972 | Synthes (USA) Trochanter Stabilization Plate for Dhs | Synthes (USA) Products LLC | LXT | Class II | |
| K000955 | Placer Model 6232 Steerable Stylet | Medtronic, Inc. | DRB | Class II | |
| K000947 | Ultrastim Electrode, Model Us4040 | Axelgaard Mfg. Co., Ltd. | GXY | Class II | |
| K000892 | Datex-Ohmeda EEG Module, M-EEG and Datex-Ohmeda EEG Headbox, N-EEG and Accessories | GE Healthcare | OLT | Class II | |
| K000890 | Chad Therapeutics Oxymatic Model 401 | Chad Therapeutics, Inc. | NFB | Class II | |
| K000844 | Absolute Hcg Pregnancy Test | Mizuho USA, Inc. | DHA | Class II | |
| K000543 | Contempro-Mist | Contemporary Products, Inc. | CAF | Class II | |
| K000433 | Pbn Hystero-Salpingography Catheter Set | Medical Device Technologies, Inc. | LKF | Class II | |
| K000313 | Tearaway Introducer Sheath | Xentek Medical, Inc. | DYB | Class II | |
| K991999 | Sterrad 100S Sterilizer | Advanced Sterilization Products | MLR | Class II | |
| K990060 | Mach 7 | Kreativ, Inc. | KOJ | Class II | |
| K001545 | Pipet Curet | Milex Products, Inc. | HHK | Class II | |
| K001084 | Trans Fx Adjustable Pin to Bar Clamp | Immedica, Inc. | LXT | Class II | |
| K001082 | Stackhouse Smoke Evacuator, Models St-3000, St 3100 | Stackhouse, Inc. | FYD | Class II | |
| K001039 | The Implex Hedrocel Modular Elliptical Acetabular Cup | Implex Corp. | LPH | Class II | |
| K994209 | Stockert V142 Series Venous Cannulae with Lighthouse Tip | LivaNova USA, Inc. | DWF | Class II | |
| K001713 | Hrw-42 Wrist Array Coil for 1.0 Tesla | Mri Devices Corp. | MOS | Class II | |
| K001660 | Mallory Head Modular Calcar | Biomet Orthopedics, Inc. | LPH | Class II | |
| K001593 | Modification to Statsign Saline Electrolyte Gel, Graham-Field Saline Electrolyte Gel | Chester Labs, Inc. | GEI | Class II | |
| K001507 | Microperforation Instrument | Smith & Nephew, Inc. | LXH | Class I | |
| K001273 | Starion Instruments Power Point Cautery Clamp | Microline Surgical, Inc | GEI | Class II | |
| K001262 | Thermal Cautery Forceps | Microline Surgical, Inc | GEI | Class II | |
| K001112 | Ge Marquette Clinical Information Center, Ge Marquette Cic | General Electric Medical Systems Information Techn | DXJ | Class II | |
| K001068 | Nbs Connecting Tube Set | Nbs Products Co | HIF | Class II | |
| K000893 | Ac Powered Thermal Cautery Unit | Microline Surgical, Inc | HQO | Class II | |
| K992532 | Vantex Central Venous Catheter with Oligon Material with or without Amc Thromboshield Coating | Baxter Healthcare Corporation | FOZ | Class II | |
| K001762 | Pulsion Continuous Pulse Contour Cardiac Output (Picco) System | Pulsion Medical Systems AG | DXG | Class II | |
| K001620 | Metrofocal Toric (Polymacon) Soft (Multifocal) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-Cut from Len | Metro Optics of Austin, Inc. | LPL | Class II |