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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K230958 | First Glove Blue Nitrile Examination Gloves Powder Free | First Glove Sdn. Bhd. | LZA | Class I | |
| K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland Ltd. | FCG | Class II | |
| K230593 | Victan | Jiangsu Haize Medical Scientific Development Co.,Ltd. | GEI | Class II | |
| K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies Inc. | DSA | Class II | |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | FMT | Class II | |
| K230030 | Excipio SV Aspiration Catheter and Tubing | Contego Medical, Inc | QEW | Class II | |
| K223841 | Kba3d | S.M.A.I.O | LLZ | Class II | |
| K223809 | PrecisionTAVI (v1.1) | Dasi Simulations | QQI | Class II | |
| K223762 | Smith & Nephew ACCORD™ Cable System | Smith & Nephew, Inc. | HRS | Class II | |
| K223523 | Sonic DL | GE Medical Systems,Llc (GE Healthcare) | LNH | Class II | |
| K222359 | Quicktome Software Suite | Omniscient Neurotechnology Pty Ltd (O8T) | LLZ | Class II | |
| K221897 | Hydrozid Precise | Bibawo Medical A/S | GEH | Class II | |
| K220706 | MyPAO Guides | Medacta International SA | PBF | Class II | |
| K230601 | Blue Nitrile Examination Gloves Powder Free | Latrile Gloves Private Limited | LZA | Class I | |
| K231233 | Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS | ConforMIS, Inc. | JWH | Class II | |
| K231184 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | MAX | Class II | |
| K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 | Shenzhen IONKA Medical Technology Co., Ltd. | OHT | Class II | |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee BioMedical, Inc. | KRH | Class II | |
| K230580 | Diode Laser System | Smedtrum Medical Technology Co. Ltd. | GEX | Class II | |
| K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | MUJ | Class II | |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | OWW | Class II | |
| K230263 | Finesse™ Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | LIT | Class II | |
| K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | DQD | Class II | |
| K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System | Fiagon GmbH | PNZ | Class II | |
| K230044 | Pre-Sure | Lazarus 3D, Inc. | LLZ | Class II | |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences LLC | MUD | Class II | |
| K223626 | Niti-S Biliary Speed D Stent | Taewoong Medical Co., Ltd. | FGE | Class II | |
| K223329 | Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) | Guangzhou Yongyi Industrial Co., Ltd. | HGX | Class II | |
| K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine | NKB | Class II | |
| K222640 | Sweden & Martina Surgical Trays | Sweden & Martina Inc | KCT | Class II | |
| K222606 | V-Hyadase | VITROMED GmbH | MQL | Class II | |
| K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products LLC | KGO | Class I | |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | IMMUNO CONCEPTS, NA, Ltd. | KTL | Class II | |
| K231229 | S-COMP Reform® POCT Navigation Instruments | Precision Spine, Inc. | OLO | Class II | |
| K231176 | Stingray LP Catheter | Boston Scientific Corporation | DQY | Class II | |
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co., Ltd. | MLR | Class II | |
| K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | QFJ | Class II | |
| K230259 | Soreal Press, Soreal CAD | Shenzhen Up3D Technology Co., Ltd. | EIH | Class II | |
| K230258 | BB 8 Sinus Dilation Kit | Excelent | LRC | Class I | |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | Dentis Co.,Ltd | NHA | Class II | |
| K223818 | Model 9160 VitaloQUB | Vitalograph Ireland Ltd. | JEH | Class II | |
| K223814 | Genesis ACTIVE Implant System | Keystone Dental Inc. | DZE | Class II | |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | GE Healthcare | QBS | Class II | |
| K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | LBH | Class II | |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation | FMI | Class II | |
| K222624 | KLS Martin LINOS Wrist System | KLS-Martin L.P. | HRS | Class II | |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | CIRCA Scientific, Inc. | FLL | Class II | |
| K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | NKB | Class II | |
| K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | FQH | Class II |