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 |
|---|---|---|---|---|---|
| K223382 | AeviceMD | Aevice Health Pte. Ltd. | DSH | Class II | |
| K222707 | IH Implant System | Sewonmedix, Inc. | DZE | Class II | |
| DEN220058 | Bt-001 | Better Therapeutics | QXC | Class II | |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | JTN | Class II | |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical | HTY | Class II | |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | |
| K230968 | VYBE RF Electrosurgical System | ShenB Co., Ltd. | GEI | Class II | |
| K230510 | MyEllevate | Cynosure, LLC | GAT | Class II | |
| K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | MNT | Class II | |
| K223806 | VERTICALE® Triangular Fixation System | Silony Medical GmbH | NKB | Class II | |
| K223780 | Lumos 3DX | 3Dio | EHD | Class II | |
| K223747 | Whitsundays Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | BZD | Class II | |
| K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC. | OWW | Class II | |
| K221056 | Argus Pb-3000 | Schiller, AG | MHX | Class II | |
| K231641 | Rotium Bioresorbable Wick | Nanofiber Solutions LLC | MAI | Class II | |
| K231358 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | KRA | Class II | |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | bioMerieux, Inc. | LON | Class II | |
| K230001 | Electric Scooter (Model: M2020) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | |
| K222015 | Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc | ODP | Class II | |
| K221058 | LungTrainer (MD2 & MD3) | Lung Trainers, LLC | BWF | Class II | |
| K220980 | Tissue Approximation System (TAS) | TAS Medical Inc | GAR | Class II | |
| K231740 | MemorialTM Gloves | Us Glove Supply | LZA | Class I | |
| K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter | Thrombolex, Inc. | QEY | Class II | |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | CarboFix Orthopedics Inc. | NKB | Class II | |
| K230901 | Premier HpSA Flex (619096) | Meridian Bioscience Inc | LYR | Class I | |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | OLP | Class II | |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | Cardinalhealth | FXX | Class II | |
| K230487 | Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co. Ltd. | EIH | Class II | |
| K230025 | IVYLASER Handhold Hair Removal Machine | Ivylaser (Beijing) Technology Co., Ltd. | OHT | Class II | |
| K222745 | Axial3D Insight | Axial Medical Printing Limited | QIH | Class II | |
| K221664 | CLEARinse CTS Specimen Collection and Transport System | Aardvark Medical | QBD | Class II | |
| K230725 | NB Implant System | ARUM DENTISTRY Co., Ltd. | DZE | Class II | |
| K231689 | iFuse TORQ® Implant System | SI-Bone, Inc. | OUR | Class II | |
| K231596 | IOB Temperature Management System | Iob Medical, Inc. | DWJ | Class II | |
| K231588 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | OWQ | Class II | |
| K231585 | Vantage PSI System | 3D Systems, Inc. | OYK | Class II | |
| K231267 | ClearTip | Finemedix | FCG | Class II | |
| K231264 | Easy On Universal Glaze & Stain | Doctus Global | EIH | Class II | |
| K231252 | Ventana™ L Spinal System | Spinal Elements, Inc | MAX | Class II | |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | NEZ | Class II | |
| K230944 | MeMed BV | MeMed Diagnostics Ltd | QPS | Class II | |
| K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific Oy | JWY | Class II | |
| K230933 | REMI Remote EEG Monitoring System | Epitel | OMC | Class II | |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | FEB | Class II | |
| K230917 | FebriDx Bacterial / Non-bacterial Point of Care Assay | Lumos Diagnostics, Inc. | QXA | Class II | |
| K230469 | Compact Wearable Pump | Lansinoh Laboratories Inc | HGX | Class II | |
| K230456 | SGM Femoral Nail System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd | HSB | Class II | |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K230052 | Inogen Rove 6 | Inogen, Inc | CAW | Class II |