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 |
|---|---|---|---|---|---|
| K081121 | Modification to Acuson X150 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound di | IYO | Class II | |
| K081056 | 21.3 (54Cm) 3M Color Lcd Monitor Ccl354i2 (Cdl2126a) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K081055 | 21.3 (54Cm) 2M Color Lcd Monitor Ccl254i2 (Cdl2125a) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | FMI | Class II | |
| K080876 | Dvx Spine System | BK Meditech Co., Ltd. | MNH | Class II | |
| K080859 | Drf 4343 | Villa Sistemi Medicali S.p.A. | JAA | Class II | |
| K080072 | MRI Patient Positioning Devices | CIVCO Medical Instruments Co., Inc. | IYE | Class II | |
| K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6) | Vitalograph Ireland Ltd. | BZG | Class II | |
| K073109 | Stalif Tt Intervertebral Body Fusion System | Surgicraft, Ltd. | OVD | Class II | |
| K071597 | Dimension Vista (R) Afp Flex(r) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model Kc600 | Siemens Healthcare Diagnostics Inc. | LOJ | Class II | |
| K081449 | Ultiguard Home Insulin Pen Needle Dispenser and Sharps Container | Ultimed, Inc. | MMK | Class II | |
| K081097 | Orthopediatrics Pediflex Flexible Nail System | Orthopediatrics Corp | HTY | Class II | |
| K081044 | Rejuvenate Modular Hip System | Howmedica Osteonics Corp | MEH | Class II | |
| K080772 | Bonemedik-Dm | Meta Biomed Co., Ltd. | LYC | Class II | |
| K080555 | Sofia Automated Tomographic Ultrasound (Atus) | Ivu Imaging Corporation | ITX | Class II | |
| K073708 | Fixed, Variable & Corpectomy Cervical Plate System | Precision Surgery, Ltd. | KWQ | Class II | |
| K071755 | Falck Applanation Tonometer (Fat2) | Falck Medical Corporation | HKY | Class II | |
| K081022 | Somatom Definition, Model As/as+ | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K080973 | Cliniqa Liquid Qc Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker Control-Low, and Linical Cardiac | Cliniqa Corporation | JJY | Class I | |
| K080703 | Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank | 4m Ventures, Inc. | FIP | Class II | |
| K080539 | Accin Unipolar Head System | Accelerated Innovation, LLC | JDI | Class II | |
| K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, Ir-40, Ir-500, Ir-600, | Abbott Medical | LGZ | Class II | |
| K071916 | Metha Hip System | Aesculap Inc | MEH | Class II | |
| K081252 | Expedium 4.5Mm Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K081069 | Gore Infinit Mesh | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K081035 | Aesculon C2, Aesculon Chf Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2 | Osypka Medical GmbH | DSB | Class II | |
| K081034 | Synergeyes Hybrid Contact Lenses - Daily Wear, Models a, M, Kc and Ps | Synergeyes, Inc. | HQD | Class II | |
| K080763 | Tablegard Pressure Relieving Patient Warming Mattress, Model: Tg 700 Ht | Talley Medical | DWJ | Class II | |
| K080588 | Scient'x Tribeca Vbr | Scien'Tx USA, Inc. | MAX | Class II | |
| K080480 | Nanocomposite Restorative Kit | Dmg USA, Inc. | EBF | Class II | |
| K080386 | Columbia 600 Electrode, Columbia 06 Leadwire | Columbia Scientific Development, LLC | GXY | Class II | |
| K080198 | Tso3 Ozone Sterilization Wrap | Tso3, Inc. | FRG | Class II | |
| K080129 | Secure Implant System (2.5/3.0Mm) | Dio Department Dsi, Inc. | DZE | Class II | |
| K080115 | I-Mini Dental Implant | Oco Biomedical | DZE | Class II | |
| K073711 | Mucograft Collagen Matrix | Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL | Class II | |
| K073694 | Ivent 2001 MRI Conditional | Versamed Medical Systems, Inc. | CBK | Class II | |
| K073078 | Rapid Tox Cup | American Bio Medica Corp. | LAG | Class II | |
| K073051 | Medrad Continuum Mr Infusion System with Wireless Remote Accessory | Medrad, Inc. | FRN | Class II | |
| K072582 | Provox Micron Hme | Atos Medical AB | JOH | Class II | |
| K072178 | Athena Multi-Lyte Hsv 1 & 2 Igg Test System | Zeus Scientific LLC | MXJ | Class II | |
| K063723 | Impella Recover Lp 2.5 Percutaneous Cardiac Support System | Abiomed, Inc. | KFM | Class II | |
| K063532 | Bard E Luminexx Biliary Stent | Bard Peripheral Vascular Inc | FGE | Class II | |
| K081416 | Palomar Aspire Laser Platform | Palomar Medical Products, Inc. | GEX | Class II | |
| K081359 | Genesis Ecp | Scottcare Corporation | DRN | Class II | |
| K081278 | Omega 3 Trochanteric Stabilizing Plate | Howmedica Osteonics Corp | KTT | Class II | |
| K081257 | Cg-6108 Act-3L Continuous ECG Monitor & Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | DSI | Class II | |
| K081194 | Interplate Peek Cervical Interbody Fusion Device (Ifd) | RSB Spine LLC. | OVE | Class II | |
| K081102 | Vsu - Visionsense Stereoscopic Vision System | Visionsense, Ltd. | GWG | Class II | |
| K080952 | 15-Inch (38 Cm) Color Lcd Monitor Cdl1576a | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K080951 | 19-Inch (48Cm) 1.3M Color Lcd Monitor Cdl1909a | Totoku Electric Co., Ltd. | LLZ | Class II |