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 |
|---|---|---|---|---|---|
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | GEI | Class II | |
| K251592 | SteriHub™ Disinfecting Device and Protective Cover | 1World Vista Medical | QBP | Class II | |
| DEN250007 | Delivery Date AI | Ultrasound AI Inc. | SHE | Class II | |
| K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | OVB | Class II | |
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | BioDynamik | JDW | Class II | |
| K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K253545 | Vulcan Spinal System | K2M, Inc | NKB | Class II | |
| K253140 | CollOvine™ Wound Powder | Ovigenex LLC | KGN | Unclassified | |
| K252751 | Earflo (EF001) | Earflo Company | MJV | Unclassified | |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | Shenzhen RF Tech Co., Ltd. | MOS | Class II | |
| K252175 | LANDR Contact LENS Case | Fourth Axis LLC | LRX | Class II | |
| K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | ETN | Class II | |
| K251515 | Solidex® Ti-Links and Screws | Creodent Hudson Valley | NHA | Class II | |
| K254236 | Peel-Away Introducer Sheath | Vascutech Medical, LLC | DYB | Class II | |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | GXY | Class II | |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | DQK | Class II | |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | LLZ | Class II | |
| K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | Ethicon, Inc | GAM | Class II | |
| K253780 | SIGNA™ Bolt | GE Healthcare | LNH | Class II | |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | FUJIFILM Corporation | FDS | Class II | |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | IYO | Class II | |
| K252873 | Q Interbody Instruments | K2M, Inc | OLO | Class II | |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | DQD | Class II | |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | OLO | Class II | |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | GEI | Class II | |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona Inc | KCT | Class II | |
| K251577 | Laia Xr | Augmented Reality Software S.L. | LLZ | Class II | |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K251507 | Integre Lio | Quantel Medical | HQF | Class II | |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | QDQ | Class II | |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | HGX | Class II | |
| K251218 | SafeBeat Rx App | Safebeat RX Inc. | DQK | Class II | |
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | MSV | Class II | |
| K243348 | Athelas Home | Athelas | GKZ | Class II | |
| DEN250006 | Amferia Wound Dressing | Amferia AB | SHA | Class II | |
| K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister | Argon Medical Devices, Inc | QEW | Class II | |
| K253959 | Primevision 3D | Dentsply Sirona Inc | OAS | Class II | |
| K253779 | SIGNA™ Sprint Select | GE Healthcare | LNH | Class II | |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra Inc. | QEW | Class II | |
| K251517 | Encora X1 | Encora, Inc | QBC | Class II | |
| K260104 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | |
| K260038 | E3D™-C Interbody System | Evolution Spine, LLC | OVE | Class II | |
| K260012 | UltraScore™ Focused Force PTA Balloon | Bard Peripheral Vascular Inc | PNO | Class II | |
| K252623 | G7® Revision Acetabular System | Zimmer GmbH | LPH | Class II | |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd | FYA | Class II | |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc | MAX | Class II | |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II |