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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | The Binding Site Group Ltd. | DFH | Class II | |
| K150274 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System | Infopia Co, Ltd. | NBW | Class II | |
| K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions Pv .014 Platinum | Volcano Corporation | OBJ | Class II | |
| K143512 | ActiSpec Activity Monitor | Sleep Modus, Inc. | ISD | Class II | |
| K143203 | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe | Medwaves Incorporated | NEY | Class II | |
| K142976 | UltraTENS | Shenzhen Dongdixin Technology Co., Ltd. | IMI | Class II | |
| K152097 | Retraction Aspirator | Inari Medical, Inc. | QEW | Class II | |
| K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07 | Ningbo Lecount Medical Technology Co., Ltd. | IOR | Class I | |
| K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve | United States Endoscopy Group, Inc. | ODC | Class II | |
| K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | GXY | Class II | |
| K143648 | BD MAX Enteric Parasite Panel, BD MAX Instrument | Becton Dickinson & Co | PCH | Class II | |
| K142760 | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | K.S. Choi Corp. | MQX | Class II | |
| K142351 | 25-Hydroxy Vitamin Ds EIA | Immunodiagnostic Systems Ltd. | MRG | Class II | |
| K151343 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K150685 | Skynector CPAP Mask | Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. | BZD | Class II | |
| K150205 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ | Class II | |
| K152045 | SALVATION® External Fixation System | Wrightmedicaltechnologyinc | KTT | Class II | |
| K151756 | Sterispine Lc Cage | Safe Orthopaedics | MAX | Class II | |
| K151516 | Capillus82 | Capillus, LLC | OAP | Class II | |
| K151422 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | |
| K151333 | LightStim for Pain LED Belt | LED Intellectual Properties LLC | ILY | Class II | |
| K151213 | UCP Drug Test Mini Cups | Ucp Biosciences, Inc. | DKZ | Class II | |
| K151087 | CS 8100SC, CS8100SC Access | Trophy | MUH | Class II | |
| K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer | Kuraray Noritake Dental, Inc. | EMA | Class II | |
| K150673 | SYNFIX Evolution Secured Spacer System | Synthes (USA) Products LLC | OVD | Class II | |
| K143692 | GranOSTM - beta tricalcium phosphate synthetic bone granules | Tcm Associates, Ltd. | MQV | Class II | |
| K143529 | UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer | MEDLINE INDUSTRIES, LP - Northfield | NUC | Class II | |
| K143487 | Lifelines iEEG | Kvikna Ehf | OLT | Class II | |
| K143444 | SynePure Wound Cleanser | Synedgen, Inc. | FRO | Unclassified | |
| K143348 | BC-3600 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | GKZ | Class II | |
| K152186 | HealthMyne PACS | Healthmyne, Inc. | LLZ | Class II | |
| K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Frontier Medical Devices, Inc. | JDQ | Class II | |
| K151341 | Turbo High-Flow Non-coring Needle | Norfolk Medical | FMI | Class II | |
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | Stryker Corp. | FCS | Class II | |
| K151153 | Pirouette 018 | Arravasc Limited | LIT | Class II | |
| K151117 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | GCJ | Class II | |
| K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | Arthrex GmbH | MBI | Class II | |
| K150481 | Cascadia Interbody System | K2M, Inc | MAX | Class II | |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | FUJIFILM Healthcare Americas Corporation | FDA | Class II | |
| K143354 | Natrelle 133 Plus Tissue Expander | Allergan | LCJ | Unclassified | |
| K143325 | OC-Light S FIT | Eiken Chemical Co., Ltd. | KHE | Class II | |
| K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing, | Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP | Class II | |
| K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K152033 | Cook ECM Powder | Cook Biotech Incorporated | KGN | Unclassified | |
| K151998 | TraceIT Tissue Marker - 3mL | Augmenix, Inc. | NEU | Class II | |
| K151837 | CS 3D Imaging | Trophy | LLZ | Class II | |
| K151371 | Corporate Dental Imaging (CDI) Application | U.S. Army Dental Command (Dencom) | LLZ | Class II | |
| K151180 | ScandiDos Delta4 Phantom+ | Scandidos, Inc. | IYE | Class II | |
| K150519 | ManipulatOR PRO, ManipulatOR | Gynetech Pty., Ltd. | LKF | Class II |