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 |
|---|---|---|---|---|---|
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | Abbott Medical | PDJ | Class II | |
| K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | Polymer Technology Systems | NBW | Class II | |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | Cook Incorporated | LJT | Class II | |
| K150467 | Retina Workplace | Carl Zeiss Meditec Inc | NFJ | Class II | |
| K150446 | Erchonia Zerona 6 headed scanner EZ6 | Erchonia Corporation | OLI | Class II | |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | Medtronic Navigation, Inc | GEI | Class II | |
| K150151 | SmartGownTM surgical gown | Medtronic, Inc. | FYA | Class II | |
| K143660 | Milagro / Milagro Advance Interference Screw | DePuy Mitek, Inc. | MAI | Class II | |
| K143603 | Darlinghurst Vented, Darlinghurst NV-AAV | ResMed Corp | BZD | Class II | |
| K143436 | InvisionECG System | Invisionheart, Inc. | DPS | Class II | |
| K143060 | Intelli-Ox | Air Liquide Healthcare | ECX | Class I | |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | Fujirebio Diagnostics, Inc. | LTK | Class II | |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | Mentor Worldwide, LLC | MRD | Unclassified | |
| K150848 | Dose Calculator | Sun Nuclear Corporation | IYE | Class II | |
| K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | |
| K150453 | TULA Iontophoresis System with Earset | Acclarent Inc | EGJ | Class II | |
| K150090 | Zimmer Persona Personalized Knee System | Zimmer GmbH | MBH | Class II | |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | Sterilmed Inc | NLQ | Unclassified | |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | Reckitt Benckiser LLC | NUC | Class II | |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls | Immunalysis Corporation | DJG | Class II | |
| K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | HRS | Class II | |
| K142719 | E-App | GC Medtech, LLC | JAQ | Class II | |
| K142422 | cobas Cdiff Test | Roche Molecular Systems Inc | OZN | Class II | |
| K141900 | Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module | Eckert & Ziegler Bebig GmbH | MUJ | Class II | |
| K141748 | Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set | Biophor Diagnostics, Inc. | DKZ | Class II | |
| K140491 | Tanaka Zircolor Coloring Liquid, Tanaka Zircolor Dipping Liquid and Tanaka Enamel Zr Blocks | Tanaka Dental | EIH | Class II | |
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | Medtronic, Inc. | PJT | Class II | |
| K150417 | Astra Spine System | Spinecraft LLC | NKB | Class II | |
| K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Co. | PDU | Class II | |
| K150061 | Lucent; Lucent Ti-Bond Systems | Spinal Elements, Inc | MAX | Class II | |
| K143629 | U&U Bowie-Dick Test Pack | U&u Medical Technology Co., Ltd | JOJ | Class II | |
| K143561 | ELM PTA Balloon Dilatation Catheter | O'Connell Regulatory Consultants, Inc. | LIT | Class II | |
| K142567 | RETeval Visual Electrodiagnostic Device | LKC Technologies, Inc. | GWE | Class II | |
| K142291 | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | BZR | Class II | |
| K141351 | Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring System | Biotest Medical Corp. | NBW | Class II | |
| K150785 | syngo.CT Dental | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K142486 | Heine Beta 200, Heine Beta 200 S, Heine K 180 | Heine Optotechnik GmbH & Co. KG. | HLJ | Class II | |
| K151175 | ZONARE ZS3 Diagnostic Ultrasound System | Zonare Medical Systems, Inc. | IYN | Class II | |
| K151097 | Active Breathing Coordinator | Aktina Medical Corp. | IYE | Class II | |
| K151078 | Arthrex RetroFusion Screw | Arthrex GmbH | HWC | Class II | |
| K150900 | Flexicare Heated Wire Breathing Systems | Flexicare Medical Ltd. | BZE | Class II | |
| K150822 | Centurion POCT System | Orthofix SRL | NKG | Class II | |
| K150691 | Datalys Multi-Parameter Patient Monitor | Lutech Industries | MWI | Class II | |
| K150547 | .decimal Astroid Dosimetry App | .Decimal, Inc. | MUJ | Class II | |
| K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | ODP | Class II | |
| K150424 | JuggerStitch Meniscal Repair Device | Biomet Manufacturing Corp | MBI | Class II | |
| K150407 | BioFlo Midline Catheter | Boston Scientific Corporation | FOZ | Class II | |
| K150284 | IS4000 da Vinci EndoWrist Instruments | Intuitive Surgical, Inc. | NAY | Class II | |
| K150230 | SculpSure | Cynosure, LLC | PKT | Class II |