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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co.,Ltd | FYA | Class II | |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | KNS | Class II | |
| K232031 | Luna 3D | LAP GmbH Laser Applikationen | IYE | Class II | |
| K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | JPA | Class II | |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation | PHC | Class II | |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | FRN | Class II | |
| K240693 | LINQ II™ Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | MXD | Class II | |
| K240567 | CustomizedBone Service | Fin-Ceramica Faenza SpA | GXN | Class II | |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis Inc. | NGL | Class II | |
| K240284 | Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) | Shenzhen Browiner Tech Co., Ltd. | IZL | Class II | |
| K240171 | ProSeal™ Injector Plus (Model no. 421050) | Epic Medical Pte., Ltd. | ONB | Class II | |
| K233909 | Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister | Argon Medical Devices, Inc | QEW | Class II | |
| K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) | Medtronic, Inc. | NEY | Class II | |
| K233719 | FDR Visionary Suite | Shimadzu Corp. | KPR | Class II | |
| K233669 | Oec 3D | GE Healthcare | OXO | Class II | |
| K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | DQD | Class II | |
| K233604 | Btl-785S | BTL Industries, Inc | GEI | Class II | |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | QYE | Class II | |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K232049 | IS-III active Short Implant | Neobiotech Co., Ltd. | DZE | Class II | |
| K232047 | Vivace | Unimom.Co | HGX | Class II | |
| K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) | Goodman Co., Ltd. | PNO | Class II | |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | DSY | Class II | |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | Hyundae Meditech Co., Ltd. | NEW | Class II | |
| K240045 | QStat Cartridge | Hemosonics, LLC | QFR | Class II | |
| K234150 | Lucent® XP | Spinal Elements, Inc | MAX | Class II | |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Medical | QAT | Class II | |
| K234097 | Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Ever Growth (Vietnam) Co., Ltd. | LZA | Class I | |
| K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics Inc. | NKG | Class II | |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | MUE | Class II | |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | Penumbra Inc. | QJP | Class II | |
| K232891 | Carpl (Carpl) | Carpl Ai, Inc. | LLZ | Class II | |
| K232253 | Modius Stress | Neurovalens | QJQ | Class II | |
| K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | Wuxi Jiajian Medical Instrument Co., Ltd | NUH | Class II | |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences | LIO | Class I | |
| DEN210049 | Medline ART Skin Harvesting System | MEDLINE INDUSTRIES, LP - Northfield | QYK | Class II | |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28 | MBI | Class II | |
| K233733 | SyMRI | Syntheticmr AB (Publ.) | LNH | Class II | |
| K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K233069 | Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. | PUR | Class II | |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | BioFire Diagnostics, LLC | QOF | Class II | |
| K231984 | Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) | Shenzhen Hingmed Medical Instrument Co., Ltd | DXN | Class II | |
| K231793 | RODIN 3D Resin SPLINT, Hard/Flex | Belport Company, Inc., Gingi-Pak | MQC | Unclassified | |
| K231132 | J & P Click Attachments | J & P Dental Technologies | NHA | Class II | |
| K240620 | Cube Navigator | Medical Templates AG | LLZ | Class II |