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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K220685 | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | Qingdao Hightop Biotech Co., Ltd. | NFT | Class II | |
| K220559 | 17Hq901g-B | LG Electronics.Inc | MQB | Class II | |
| K220041 | HandPICO | Vydence Medical Industria e Comercio Ltda | GEX | Class II | |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | OLO | Class II | |
| K212434 | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut fur Physik und Medizin GmbH | KOI | Class II | |
| K212346 | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 | Shenzhen Pango Medical Electronics Co., Ltd | FLL | Class II | |
| K211529 | NAVIRFA Scope | Navifus Corporation | IYO | Class II | |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | Alicn Medical Shenzhen, Inc | FLL | Class II | |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | NHB | Class II | |
| K220705 | MyKnee R Pin Positioners | Medacta International SA | JWH | Class II | |
| K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular | PNO | Class II | |
| K220700 | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine | Yian Medical Technology (Haining) Co., Ltd. | IZL | Class II | |
| K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics | MLZ | Class II | |
| K214065 | ROSA ONE Brain application | MedTech SAS | HAW | Class II | |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc | LJS | Class II | |
| K213526 | Aurora-RT | Magnettx Oncology Solutions Ltd | IYE | Class II | |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | C.R. Bard Inc | DQY | Class II | |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 | Alicn Medical Shenzhen, Inc | FLL | Class II | |
| K211707 | BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd | JSM | Class I | |
| K211036 | Plus Medical Chemotherapy Gown | Foshan Nanhai Plus Medical Co Ltd | FYA | Class II | |
| K201302 | LiveOne | Livemetric (Medical) S.A. | DXN | Class II | |
| DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics, Inc. | QSE | Class II | |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | MUD | Class II | |
| K220791 | Surgical and Prosthetic Trays | Dentsply Sirona Inc | KCT | Class II | |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | KRO | Class II | |
| K220311 | Cardiovascular Angiography System | Allengers Medical Systems Limited | OWB | Class II | |
| K220306 | ECGenius System | Cath Vision ApS | DQK | Class II | |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs Ltd. | JOY | Class II | |
| K213594 | Echolaser X4 | Elesta SpA | GEX | Class II | |
| K213302 | exoplan | Exocad GmbH | LLZ | Class II | |
| K212915 | MVision AI Segmentation | MVISION AI Oy | QKB | Class II | |
| K212064 | Orchid Safety Release Valve(TM) | Linear Health Sciences LLC | QOI | Class II | |
| K220341 | ARx Modular Spinal System | Life Spine | NKB | Class II | |
| K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | |
| K213877 | ExactechGPS® System | Blue Ortho | OLO | Class II | |
| K213837 | Arthrx Fracture Plates | Arthrex GmbH | HRS | Class II | |
| K212348 | ALPHALOK™ Plating System | Vilex LLC | HRS | Class II | |
| K211180 | Liver Suite | GE Medical Systems SCS | JAK | Class II | |
| DEN200063 | Kerasave | Al.chi.mi.a. SRL | QCW | Class II | |
| K220243 | Ultiri Measurement System | Abbott Medical | DQK | Class II | |
| K221006 | GIA Stapler with Tri-Staple Technology | Medtronic, Inc. | GDW | Class II | |
| K221005 | EEA Circular Stapler with Tri-Staple Technology | Medtronic, Inc. | GDW | Class II | |
| K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K220899 | Oxehealth Vital Signs | Oxehealth Ltd | QME | Class II | |
| K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions LLC | MRZ | Class II | |
| K220684 | Oryx Cloud Imaging | Oryx Dental Software, Inc. | LLZ | Class II | |
| K220608 | Accu-Chek FastClix Blood Lancing System | Roche Diabetes Care, Inc. | QRL | Class II | |
| K220590 | aPROMISE X | Exini Diagnostics AB | LLZ | Class II | |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | FRN | Class II |