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 |
|---|---|---|---|---|---|
| K180565 | Peak Ns033cf, Peak Ns017cf | Neosil Co., Ltd. | ELW | Class II | |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | Case Medical, Inc. | KCT | Class II | |
| K172983 | HealthCCS | Zebra Medical Vision, Ltd. | JAK | Class II | |
| K181343 | HeartSee Cardiac P.E.T. Processing Software | Bracco Diagnostics, Inc. | KPS | Class II | |
| K181093 | SyMRI | Syntheticmr AB | LNH | Class II | |
| K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | LZA | Class I | |
| K180260 | Powder Free Vinyl Patient Examination Gloves (Yellow, White) | Shanxi Hongjin Plastic Technology Co., Ltd | LYZ | Class I | |
| K180124 | ZQuiet | Sleeping Well, LLC | LRK | Class II | |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corp. | OQI | Class II | |
| K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | FRN | Class II | |
| K172823 | Portex NRFit Epidural Needles | Abbott Medical | BSP | Class II | |
| K172783 | Access hs Tnl | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| DEN170043 | DreaMed Advisor Pro | Dreamed Diabetes Ltd | QCC | Class II | |
| K181281 | Altus Spine Pedicle Screw System | Altus Partners | NKB | Class II | |
| K180959 | Phenom 27 Catheter | Cathera, Inc. | DQY | Class II | |
| K180849 | Vinyl Examination Glove (Clear, Non-Colored) | Huifu Trading Co., Ltd. | LYZ | Class I | |
| K180766 | Endiscope, Endiscope Cervical | Elliquence LLC | HRX | Class II | |
| K180722 | CAPERE Thrombectomy System | Kp Medcure, Inc. | QEW | Class II | |
| K180649 | BeautiCem Veneer Kit | Shofu Dental Corp. | EBF | Class II | |
| K173803 | Omnican fine | B.Braun Medical, Inc. | FMI | Class II | |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System | Medos International SARL | MQP | Class II | |
| K173503 | Pollogen Legend System | Pollogen Ltd | GEI | Class II | |
| K173200 | SOFIA Plus Aspiration Catheter | Terumo Cardiovascular Systems Corporation | NRY | Class II | |
| K172961 | Liac Hwl | Sit Sordina Iort Technologies SpA | IYE | Class II | |
| K172835 | GRI-Alleset Veress Needle | Gri Medical & Electronic Technology Co., Ltd. | HIF | Class II | |
| K172821 | Ti-one 101 TS Dental Implant System | Hung Chun Bio-S Co., Ltd. | DZE | Class II | |
| K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corporation | LZA | Class I | |
| K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers Inc. | HQD | Class II | |
| K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | Supervision Optimax Sdn Bhd | LPL | Class II | |
| K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx Inc. | MJN | Class II | |
| K180660 | Avanti | Optovue Inc. | OBO | Class II | |
| K180449 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | FCG | Class II | |
| K180332 | 17Hk700g-W | LG Electronics Inc. | MQB | Class II | |
| K180306 | Nexy | Next Sight SRL | HKI | Class II | |
| K173706 | Piccolo Implants and Accessories | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K173189 | Lumfuse TP | Precifit Medical, Ltd. | MAX | Class II | |
| K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | MWJ | Class II | |
| K173070 | HSW Resection Instruments | Henke-Sass Wolf, GmbH. | HIH | Class II | |
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | Apk Technology Co., Ltd | DQA | Class II | |
| K172725 | VT Dressing Kits | Carilex Medical, Inc. | OMP | Class II | |
| K181264 | QLAB Advanced Quantification Software | Philips North America LLC | LLZ | Class II | |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co. Ltd. | NUH | Class II | |
| K180947 | Orthopantomograph OP 3D | Palodex Group Oy | OAS | Class II | |
| K180839 | At 030 | Carl Zeiss Meditec Inc | HKY | Class II | |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | HSX | Class II | |
| K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | ONN | Class II | |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | GENEA BIOMEDX Pty Ltd. | MQG | Class II | |
| K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | FTL | Class II | |
| K173577 | Guarded Luer Connector | Intl. Medical Industries | LHI | Class II | |
| K173573 | Tetric CAD | Ivoclar Vivadent, Inc. | EBF | Class II |