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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics Inc. | JFM | Class II | |
| K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | NKB | Class II | |
| K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | OWB | Class II | |
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | Laurimed, LLC | ERL | Class II | |
| K163224 | JAZZ SOLO Sensor | Jazz Imaging | MUH | Class II | |
| K163118 | FLEX Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Artivion, Inc. | DXZ | Class II | |
| K162412 | Hoggan Scientific® microFET2™ | Hoggan Scientific LLC | LBB | Class II | |
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics Inc. | JGS | Class II | |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | CooperSurgical, Inc. | MQF | Class II | |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | Apyx Medical Corporation | GEI | Class II | |
| K170095 | Vial2Bag Direct Connect | Medimop Medical Project, Ltd. | LHI | Class II | |
| K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar | Medtronic, Inc. | GCJ | Class II | |
| K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions Inc | HWC | Class II | |
| K163450 | VIVA combo RF System | Starmed Co.,Ltd | GEI | Class II | |
| K163409 | Rampart(TM) T Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | |
| K163307 | Expro Elite Snare, Sympro Elite Snare | Vascular Solutions LLC | MMX | Class II | |
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | Osprey Medical, Inc. | DXT | Class II | |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment | Straumann USA, LLC | DZE | Class II | |
| K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc | FPA | Class II | |
| K162394 | CRC-77tHR | Mirion Technologies (Capintec), Inc. | KPT | Class II | |
| K161898 | Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set | Beijing Fert Technology Co., Ltd. | FPA | Class II | |
| K161733 | Inspire Svr 1200, Inspire 6F C, Inspire 8F C | Corcym Inc. | DTN | Class II | |
| K161681 | Nipro SafeTouch IV Catheter | Nipro Medical Corporation | FOZ | Class II | |
| K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | |
| K170403 | CenterCross Ultra LV Catheter | Roxwood Medical, Inc. | DQY | Class II | |
| K170346 | PRECICE Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K162919 | Male Latex Condoms | Zhejiang Xiangban Latex Products Co., Ltd. | HIS | Class II | |
| K162906 | Flexi-Seal PROTECT Fecal Management System | ConvaTec Limited | KNT | Class II | |
| K162870 | CIMLRE F1 and CIMILRE S3 | Cimilre Co., Ltd. | HGX | Class II | |
| K162311 | Straumann PrefGel | Straumann USA, LLC | KJJ | Unclassified | |
| K161865 | iSage Rx (iSage Rx Basal Insulin Titration) | Isag Rx, Inc. | NDC | Class II | |
| K160721 | Vado Steerable Sheath | Kalila Medical, Inc. | DYB | Class II | |
| K160067 | RenovoCath | RenovoRx, Inc. | MJN | Class II | |
| K170430 | TSolution One Surgical System Model 210 | Think Surgical Inc. | OLO | Class II | |
| K163436 | Greiner Vacuette Urine Count and Culture, Mannitol tube | Greiner Bio-One Na, Inc. | JSM | Class I | |
| K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | FRO | Unclassified | |
| K162325 | Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw | Exactech, Inc. | PHX | Class II | |
| K162035 | GMK Sphere | Medacta International SA | JWH | Class II | |
| K162033 | SALVATION External Fixation System | Wright Medical | KTT | Class II | |
| DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | Ventana Medical Systems Inc | PRB | Class II | |
| K170350 | ToeMATE® Hammertoe Correction System | Arthrosurface, Inc. | HWC | Class II | |
| K170331 | Cyber Ho | Quanta System Inc. | GEX | Class II | |
| K170314 | ACL AcuStar | Instrumentation Laboratory Co. | JPA | Class II | |
| K170167 | True 3D Viewer Software | Echopixel, Inc. | LLZ | Class II | |
| K170164 | 3D OCT-1 Maestro | Topcon Corp. | OBO | Class II | |
| K170058 | TheraView TBI | Cablon Medical B.V. | IYE | Class II | |
| K163575 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | |
| K163552 | iPulse SmoothSkin BARE Hair Removal Device | Cyden Limited | OHT | Class II | |
| K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | FUJIFILM Healthcare Americas Corporation | JAK | Class II |