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 |
|---|---|---|---|---|---|
| K012664 | Ultra Thick Male Latex Condom with Silicone Lubricant | Innolatex Sdn. Bhd | HIS | Class II | |
| K012662 | Se-100 Vacuum Erection Device | Vts, Inc. | LKY | Class II | |
| K012647 | Tonoport V | Par Medizintechnik GmbH | DXN | Class II | |
| K012639 | Se-300 Vacuum Therapy System | Vts, Inc. | LKY | Class II | |
| K012630 | Reprocessed Linvatec Arthroscopic Burs | Alliance Medical Corp. | HRX | Class II | |
| K012620 | Se-200 | Vts, Inc. | LKY | Class II | |
| K012619 | Vt-1 | Vts, Inc. | LKY | Class II | |
| K013561 | Lightspeed 4.0 CT Scanner System | GE Healthcare | JAK | Class II | |
| K013394 | Liftloc Safety Infusion Set | Specialized Health Products, Inc. | FPA | Class II | |
| K013378 | Ebi Xfix Dfs System | Ebi, LLC | KTT | Class II | |
| K013339 | Permanent Pacing Lead W/polaris Coated Tips, Various Models | Oscor Inc. | DTB | Class III | |
| K013073 | Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima and Saf-T-Intima Intravascular Catheters | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K012885 | Neuromove Nm900 | Dan Med, Inc. | IPF | Class II | |
| K012844 | Marosis Pacs | Marotech, Inc. | LLZ | Class II | |
| K012725 | Tissue Grasping Forceps, Scissors, Clamps and Dissectors for Laparoscopic Surgeries | Endo-Therapeutics, Inc. | GEI | Class II | |
| K012724 | Smith & Nephew Vascular Videoendoscope System, Model 7209273 | Smith & Nephew, Inc. | LYK | Class II | |
| K012720 | Tulsa Contra Angles | Dentsply Intl. | EFB | Class I | |
| K012682 | Reprocessed Laser Probe | Sterilmed Inc | GEX | Class II | |
| K012679 | Reprocessed RF Arthroscopy Probes | Sterilmed Inc | GEI | Class II | |
| K012652 | Reprocessed Dyonics Arthroscopic Burs | Alliance Medical Corp. | HRX | Class II | |
| K012624 | Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited Reuse Blade, Arthroscopic Burs | Medical Instruments Technology, Inc. | HRX | Class II | |
| K012579 | Reprocessed Phaco Tips | Sterilmed Inc | NKX | Class II | |
| K012326 | Wiener Lab.mg-Color Aa, Model 2X50 Ml Cat. N 1580001 | Wiener Laboratories Saic | JGJ | Class I | |
| K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | Acrymed, Inc. | MGQ | Unclassified | |
| K011812 | Spectrum Ventricular Catheter | Cook Inc. | NHC | Class II | |
| K011709 | Uni-Gold Strep a Test Kit | Trinity Biotech, PLC | GTZ | Class I | |
| K011196 | Iquantify, Version 1.0 | Insightful Corporation | LLZ | Class II | |
| K010819 | 3Cc Nmt Safety Syringe | New Medical Technology, Ltd. | MEG | Class II | |
| K013531 | Qwiksim Virtual Simulation System; Version 2.00 | Elekta Limited | KPQ | Class II | |
| K013522 | Somatom P30 CT Systems | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K013521 | Gemini Imaging System | Philips North America LLC | JAK | Class II | |
| K013382 | Modification to: Stackable Cage System | Depuyacromed | MQP | Class II | |
| K013350 | Modification to Depuy C-Stem System | Depuy Orthopaedics Inc. | JDI | Class II | |
| K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | GEI | Class II | |
| K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | MNI | Class II | |
| K013195 | Haemophilus/streptococcus Pneumoniae (Hp)mic Susceptibility Plates | Trek Diagnostic Systems, Ltd. | LTT | Class II | |
| K013124 | Modification to Scooper Drug/adulteration Test Cup | Branan Medical Corp. | DJJ | Class II | |
| K012987 | Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium Analyzer | Phoenix Diagnostics, Inc. | JIX | Class II | |
| K012925 | Dur-8, Models Dur-8 | Circon Video | FGB | Class II | |
| K012700 | Vanguard Reprocessed Endoscopic Instruments | Stryker Sustainability Solutions | GEI | Class II | |
| K012655 | Congruent Bone Plate System | Acu Med, Inc. | HRS | Class II | |
| K012635 | Reprocessed Stryker Arthroscopic Shavers | Alliance Medical Corp. | HRX | Class II | |
| K012613 | Reprocssed Linvatec Shavers | Alliance Medical Corp. | HRX | Class II | |
| K012611 | Reprocessed Dyonics Arthroscopic Shavers | Alliance Medical Corp. | HRX | Class II | |
| K012605 | Reprocessed Athroscopics Burs | Alliance Medical Corp. | HRX | Class II | |
| K012603 | Reprocessed Autosuture Unipolar Laparoscopic/endoscopic Instruments | Alliance Medical Corp. | NUJ | Class II | |
| K012598 | Reprocessed Laparoscopic Electric Instuments | Sterilmed Inc | NUJ | Class II | |
| K012578 | Reprocessed Endoscopic Trocar | Sterilmed Inc | NLM | Class II | |
| K012571 | Reprocessed Harmonic | Sterilmed Inc | NLQ | Unclassified | |
| K011652 | Body Fat Analyzer, Model Hbf-306 | Omron Healthcare Co., Ltd. | MNW | Class II |