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 |
|---|---|---|---|---|---|
| K161264 | TRIGEN Low Profile Bone Screws | Smith & Nephew, Inc. | HSB | Class II | |
| K160940 | Masimo Disposable Transflectance Forehead Sensor | Masimo Corporation | DQA | Class II | |
| K160872 | PolyPlex Wound Dressing | Global Health Solutions, LLC | FRO | Unclassified | |
| K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, | Y. Jacobs Medical, Inc. | NEW | Class II | |
| K160545 | Gap Endo-Exo Medullary System | Orthopediatrics Canada ULC | HSB | Class II | |
| K162971 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | KPR | Class II | |
| K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator | Inari Medical, Inc. | QEW | Class II | |
| K162743 | ViewPoint 6 | GE Healthcare | LLZ | Class II | |
| K162355 | Raycast MammoRx Carbon Fibre Breast Board | Orfit Industries NV | IYE | Class II | |
| K162316 | Pirouette 014 | Arravasc Limited | LIT | Class II | |
| K162300 | Reform® POCT System | Precision Spine, Inc. | NKG | Class II | |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Welldoc | MRZ | Class II | |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 | Nuance Medical, LLC | MLY | Unclassified | |
| K162191 | NAVILAS Laser System | Od-Os GmbH | GEX | Class II | |
| K162102 | MAGNETOM Avantofit, MAGNETOM Skyrafit | Siemens Medi Cal Solutions, Inc. | LNH | Class II | |
| K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K162043 | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | ELL | Class II | |
| K161993 | Leva® Anterior Interbody System | Spine Wave Inc | OVD | Class II | |
| K161873 | Pacel Flow Directed Pacing Catheter | Abbott Medical | LDF | Class II | |
| K161778 | ToeTac™ 10° Hammertoe Fixation System | Restore Surgical, LLC dba Instratek | HWC | Class II | |
| K161763 | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device | Smith & Nephew, Inc. | HIH | Class II | |
| K161747 | LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5 | AAP Implantate AG | HRS | Class II | |
| K161708 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | DXN | Class II | |
| K161435 | Temporary Snap Abutment | Nobel Biocare AB | NHA | Class II | |
| K161408 | Compass Cast and MAP | Centurion Medical Products, LP | DRS | Class II | |
| K161277 | ConvertX Nephroureteral Stent System | Brightwater Medical | FAD | Class II | |
| K160884 | CXI Support Catheter | Cook Incorporated | KRA | Class II | |
| K160855 | U&U Enteral Syringe | U&u Medical Technology Co., Ltd | PNR | Class II | |
| K160761 | Dw-1C | Dongwon Medical Co.,Ltd. | NEW | Class II | |
| K160594 | MRWire Guide Wire | NANO4IMAGING GmbH | DQX | Class II | |
| K153773 | Disposal Lens Cleaning Sheath | Olympus Medical Systems Corp. | GCJ | Class II | |
| K153021 | Fingertip Pulse Oximeter A310 | Amemo, Inc. | DQA | Class II | |
| K152906 | Disposable High Pressure Injector Syringe | Wuxi Yushou Medical Appliances Co., Ltd | DXT | Class II | |
| K163185 | OptiLux LED Illuminator | Isolux, LLC | HBI | Class II | |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | Dio Medical Co., Ltd. | ODP | Class II | |
| K162175 | Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less | Vietglove Corporation | LYY | Class I | |
| K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics Inc | OOK | Class II | |
| K162024 | AltiVate Anatomic Shoulder System | Encore Medical, LP | KWS | Class II | |
| K161944 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | Shandong Baisheng Medical Products Co., Ltd. | LZA | Class I | |
| K161891 | HC Primer | Shofu Dental Corp. | KLE | Class II | |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex GmbH | HSD | Class II | |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | Sterilmed Inc | OWQ | Class II | |
| K161457 | XEN Glaucoma Treatment System | Allergan | KYF | Class II | |
| K160786 | RODO Abutment System | Rodo Medical, Inc | NHA | Class II | |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | Diazyme Laboratories, Inc. | LCP | Class II | |
| K160656 | CorSens | Corsens Medical, Ltd. | DXR | Class II | |
| K160508 | Electronic Pulse Stimulator | Beijing Choice Electronic Technololgy Co., Ltd. | NUH | Class II | |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | Hager & Meisinger GmbH | NHA | Class II | |
| K162994 | Capillus302, Capillus312, Capillus352 | Capillus, LLC | OAP | Class II | |
| K162577 | Dosimetry Check Version 5 Release 1 | Math Resolutions, LLC | IYE | Class II |