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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | LZO | Class II | |
| K143376 | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K143197 | Nice1 | Nice Recovery Systems LLC | IRP | Class II | |
| K142933 | Biomet Tibial trays | Zimmer GmbH | JWH | Class II | |
| K142697 | NExCT 7 | Samsung HME America, Inc. | JAK | Class II | |
| K142630 | Instru-Safe Instrument Protection System | Summit Medical, LLC | KCT | Class II | |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | JMS North America Corp. | FIE | Class II | |
| K142502 | Alians Ulna Locking Plating System | Newclip Technics | HRS | Class II | |
| K142427 | Tissue Containment System; 10, 14, 17, 25 | Applied Medical Resources Corp | GCJ | Class II | |
| K142328 | nvc | Nvision Biomedical Technologies, Inc | ODP | Class II | |
| K142326 | HP Tissue Matrix | LifeCell Corp | FTM | Class II | |
| K142151 | Sensititre 18-24 Hour Susceptibility Plates | Thermo Fisher Scientific Oy | JWY | Class II | |
| K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | KWN | Class II | |
| K141479 | Kangaroo Enteral Feeding Set with Enfit Connectors | Medtronic, Inc. | LZH | Class II | |
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | Fujirebio Diagnostics, Inc. | OSX | Class II | |
| K140387 | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) | The Surgeon General, Department of the Army | PDT | Class II | |
| K143429 | Passage Hemostasis Valve | Merit Medical Systems, Inc. | DTL | Class II | |
| K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | MHX | Class II | |
| K143138 | AxSOS 3 Ti Locking Plate System | Stryker Trauma GmbH | HRS | Class II | |
| K143069 | HEMASORBPLUS press Resorable Hemostatic Bone Putty | Orthocon, Inc. | MTJ | Unclassified | |
| K143067 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | |
| K142807 | ANTHEM PS Total Knee System | Smith & Nephew, Inc. | JWH | Class II | |
| K142787 | Zimmer Persona Personalized Knee System | Zimmer GmbH | JWH | Class II | |
| K142771 | Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Xuanhua Metallurgical Industry Co., Ltd. | LYZ | Class I | |
| K142682 | The Lipogems System | Lipogems International S.p.A. | MUU | Class II | |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2M, Inc | KWP | Class II | |
| K142528 | AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm | Agent Medical, LLC | HWC | Class II | |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | Acon Laboratories, Inc. | JFY | Class II | |
| K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst | Siemens Healthcare Diagnostics Inc. | MRG | Class II | |
| K141721 | Bovine Pericardium Patch | Collafirm, LLC | FTM | Class II | |
| K140989 | Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine) | Hebei Hongsen Plastics Technology Co, Ltd. | KGO | Class I | |
| K140977 | Evotech Ecr | Advanced Sterilization Products | FEB | Class II | |
| K130447 | Speedy Flap System | Jeil Medical Corporation | GXN | Class II | |
| K142735 | The Optilite IgG3 kit | The Binding Site Group Ltd. | CFN | Class II | |
| K141161 | Abx Micros Es 60 CT; (Open Tube Model), (Close Tube Model) | Horiba Abx SAS | GKZ | Class II | |
| K143342 | Elecsys T-Uptake Calset | Roche Diagnostics GmbH | JIT | Class II | |
| K143339 | Mini me | Iluminage Ltd.(Formerly Syneron Beauty Ltd.) | ONF | Class II | |
| K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip | Volcano Atheromed, Inc. | MCW | Class II | |
| K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | |
| K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | IYE | Class II | |
| K143161 | Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) | Medtronic, Inc. | GEI | Class II | |
| K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | LCJ | Unclassified | |
| K142968 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Corporation | DXN | Class II | |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | Arthrosurface, Inc. | HSD | Class II | |
| K142910 | Legacy BX | Venus Concept USA Inc. | GEI | Class II | |
| K142901 | RhythmView Workstation | Topera, Inc. | DQK | Class II | |
| K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | Teleflexmedical, Inc. | FZP | Class II | |
| K142738 | artus HSV-1/2 QS-RGQ MDx Kit | Qiagen | OQO | Class II | |
| K142707 | AIS Odontoid Fracture Fixation System | Aesculap Implant System, Inc. | HWC | Class II | |
| K142701 | SMD Sr90-1 Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | KXK | Class II |