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 |
|---|---|---|---|---|---|
| K151361 | Nox RIP Belts & Cables | Nox Medical Ehf | MNR | Class II | |
| K151209 | InterOss | Sigmagraft, Inc. | NPM | Class II | |
| K150923 | Breast Pump | Guangzhou Jinxinbao Electronic Co., Ltd. | HGX | Class II | |
| K150268 | CerOX | Or-Nim Medical, Ltd. | DPW | Class II | |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L | Taiwan Surgical Corporation | FZP | Class II | |
| K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing | KCI USA, Inc. | OMP | Class II | |
| K143693 | Medline Sharps Containers | MEDLINE INDUSTRIES, LP - Northfield | MMK | Class II | |
| K143142 | JDENTALCARE Implant System | Jdentalcare SRL | DZE | Class II | |
| K152953 | Crit-Line Clip (Clic) Blood Chamber | Fresenius Medical Care Renal Therapies Group, LLC | KOC | Class II | |
| K152923 | BD ChloraShield IV Dressing with CHG Antimicrobial | Avery Dennison Belgie Bvba | FRO | Unclassified | |
| K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws | Normed Medizin-Technik GmbH | HRS | Class II | |
| K152248 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K152138 | FDR D-EVO GL Flat Panel Detector System | FUJIFILM Healthcare Americas Corporation | MQB | Class II | |
| K151901 | AirView | ResMed Corp | CBK | Class II | |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | Medela AG | HGX | Class II | |
| K151432 | NaturalLine Abutment | OT Medical GmbH | NHA | Class II | |
| K151376 | superDimension Navigation System | Medtronic, Inc. | JAK | Class II | |
| K151080 | Nihon Kohden CSM 1901 Bedside Monitor | Nihon Kohden Corp. | MHX | Class II | |
| K150963 | AnsCare ChitoClot Pad | Benq Materials Corporation | QSY | Unclassified | |
| K150688 | IdentEvent | Optima Neuroscience, Inc. | OMB | Class II | |
| K150386 | Tyece OTC TENS Device | Tyece Limited | NUH | Class II | |
| K150329 | elance Vital Signs Monitor, Central Monitor Software | GE Healthcare | MHX | Class II | |
| K150219 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical Ltd | ONB | Class II | |
| K150102 | SnoreSounds | Appian Medical, Inc. | MNR | Class II | |
| K152236 | KATOR Suture Anchor | Kator, LLC | MBI | Class II | |
| K151383 | NeuViz 128 Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | |
| K151212 | Ziostation2 | Qi Imaging, LLC | LLZ | Class II | |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Siemens Healthcare Diagnostics Inc. | MLM | Class II | |
| K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | MEG | Class II | |
| K152580 | rescuenet | Boston Scientific Corporation | FDI | Class II | |
| K152295 | Talon DistalFix Antegrade/Retrograde Femoral Nail | Orthopedic Designs North America, Inc. | HSB | Class II | |
| K151019 | SternaLock® 360 Sternal Closure System | Biomet Microfixation | HRS | Class II | |
| K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | Nantong Egens Biotech Co., Ltd. | LDJ | Class II | |
| K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | LHN | Class II | |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | Apyx Medical Corporation | GEI | Class II | |
| K152183 | EXELINT SecureTouch Safety Hypodermic Needle | Exelint International Co. | FMI | Class II | |
| K151992 | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control | Zimmer GmbH | KTT | Class II | |
| K151872 | Avance Y-Connector S | Molnlycke Health Care, US LLC | OMP | Class II | |
| K151470 | Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency | First Quality Hygienic, Inc. | HEB | Class II | |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System | Neusoft Medical Systems Co., Ltd. | KPS | Class II | |
| K150713 | syngo.CT Myocardial Perfusion | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K143584 | Pga Resorba, Pga Resoquick, Glycolon | RESORBA Medical GmbH | GAM | Class II | |
| K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | PT. Medisafe Technologies | KGO | Class I | |
| DEN150008 | INVOcell | Invo Bioscience | OYO | Class II | |
| K152899 | Philips Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K152481 | DURAFORM Dural Graft Implant | Cerenovus, Inc. | GXQ | Class II | |
| K152381 | Prelude SNAP Splittable Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K152357 | MicroSTAAR Injector System Cartridges | Staar Surgical AG | KYB | Class I | |
| K152312 | RECON system-V-TEK-IVP Plates and Screws | Normed Medizin-Technik GmbH | HRS | Class II |