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 |
|---|---|---|---|---|---|
| K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | KWD | Class II | |
| K970916 | H.v. Pulse Lavage (L31 Series) | Global Medical Products, Ltd. | FQH | Class II | |
| K970771 | Sullivan Autoset Portable II Nasal CPAP System | ResMed Corp | BZD | Class II | |
| K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | CGA | Class II | |
| K970680 | Glory | Elscint, Inc. | IZH | Class II | |
| K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K970514 | Disposable Transrectal/transvaginal/endocavity Ultrasound Needle Instrument Guide | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K970513 | General Purpose Tranducer Cover | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K970049 | Bsc, Sonicath Ultra Imaging Catheter 3.2F/20mhz(37410/456221 & Bsc, Sonicath Ultra Imaging Catheter 2.9F/20mhz/37411/ | Cardiovascular Imaging Systems, Inc. | ITX | Class II | |
| K965065 | Teca. Millennium | Medelec, Ltd. | GWF | Class II | |
| K964947 | Photon Radiosurgery System (Prs) | Photoelectron Corporation | JAD | Class II | |
| K964688 | Long Medium Palmaz-Schatz Balloon Expandable Stent | Cordis US Corp. | FGE | Class II | |
| K964206 | Nucletron Plato External Beam Planning Rts V2 and Rts 3D V2 | Nucletron BV | IYE | Class II | |
| K963932 | Preloaded Soft Tissue Anchor | Linvatec Corporation | MBI | Class II | |
| K940954 | Synaptic 3000 | The Synaptic Corp. | GZJ | Class II | |
| K972072 | Surgitron Model Ffpf-Emc | Ellman Intl., Inc. | GEI | Class II | |
| K971547 | Playtex Tampons #11197, Playtex Gentle Glide, Soft Comfort and Slimfits Tampons | Playtex Products, Inc. | HIL | Class II | |
| K965222 | Microject Model Pca-1 | Microject, Inc. | MEB | Class II | |
| K964942 | Infection Control Cartridge | Dentalpure Corp. | EIA | Class I | |
| K964650 | Tcp-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | LPH | Class II | |
| K964509 | Implex a-240 Hep Acetabular Cup System | Implex Corp. | LPH | Class II | |
| K964015 | Indicard Test | Litmus Concepts, Inc. | MJM | Class I | |
| K972161 | Bovie Model X15 | Maxxim Medical | GEI | Class II | |
| K972080 | Qualitrol Dhp Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control Levels 1, 2 and 3 | Consolidated Technologies, Inc. | JJY | Class I | |
| K971978 | Graft Harvesting Sawblades | Wrightmedicaltechnologyinc | GFA | Class I | |
| K971725 | Opus Progesterone | Behring Diagnostics, Inc. | JLS | Class I | |
| K971577 | Focus-Pv Balloon Dilatation Catheter | Cardiovascular Dynamics, Inc. | LIT | Class II | |
| K971573 | N-Geneous Ldl Cholesterol Reagent, N-Geneous Ldl Cholesterol Calibrator, Genzyme Ldl Cholesterol Control Set | Genzyme Corporation | LBR | Class I | |
| K971289 | Sscs (Segmental Spinal Correction System) | Osteotech Inc | KWP | Class II | |
| K971059 | Universal Drive System | Linvatec Corporation | HRX | Class II | |
| K971020 | Lsf Triad Total Hip System | Osteoimplant Technology, Inc. | LPH | Class II | |
| K971010 | Peripheral Transluminal Angioplasty Catheters | Cordis US Corp. | LIT | Class II | |
| K970809 | Bendable Tissue Coagulating Electrode with Bending Tool | Somnus Medical Technologies, Inc. | GEI | Class II | |
| K970149 | Legionella Elisa Test System | Zeus Scientific LLC | LHL | Class II | |
| K964374 | Sarns Venous Return Catheters with Duraflo Treatment | 3M Healthcare | DWF | Class II | |
| K964373 | Sarns Arterial Cannulae with Duraflo Treatment | 3M Healthcare | DWF | Class II | |
| K964019 | Morphee Plus Alpha | Medtronic, Inc. | BZD | Class II | |
| K971976 | Diascreen Reagent Strips | Dia-Screen Corp. | LJX | Class I | |
| K971967 | Bun | Carolina Liquid Chemistries | CDQ | Class II | |
| K971908 | Crea or Creatinine | Carolina Liquid Chemistries | CGX | Class II | |
| K971449 | Vacutainer Brand Plus Tube with Edta Anticoagulant(multiple) | Becton Dickinson Vacutainer Systems | GIM | Class II | |
| K971439 | Storz Microflow and Storz Standard Phacoemulsification Needles | Storz Instrument Co. | HQC | Class II | |
| K971428 | Coagulation Control Plasma(abnormal)level 0 | Pacific Hemostasis | GGN | Class II | |
| K971379 | Tinaquant Rheumatoid Factor Assay | Boehringer Mannheim Corp. | DHR | Class II | |
| K971291 | Heartport Endoarterial Return Cannula | Heartport, Inc. | DWF | Class II | |
| K971065 | Dentica Pulsed Nd: Yag Laser Systems and Accessories | Xintec Corporation | GEX | Class II | |
| K971032 | Danavox Models 163/162 Bte | GN Danavox, Inc. | ESD | Class I | |
| K971031 | Audallion III Hearing System | GN Danavox, Inc. | ESD | Class I | |
| K971024 | Softscan | Sahar Technologies, Inc. | GEX | Class II | |
| K970992 | Premier Nitrospray Plus and Premier Nitrospray Lite Plus | Premier Dental Products Co | GEH | Class II |