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 |
|---|---|---|---|---|---|
| K173382 | Vantage Galan 3T, V4.6 | Toshibamedical Systems Corporation | LNH | Class II | |
| K173299 | Dragon X Spsl4hc, Dragon X Spsl8hc | Sedecal S.A. | IZL | Class II | |
| K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | DXJ | Class II | |
| K172935 | Embrace | EMPATICA S.r.l. | POS | Class II | |
| K172896 | Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 | Shenzhen Jiacom Technology CO., Ltd. | DXN | Class II | |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | OLW | Class II | |
| K172816 | TiGer Shark™ System | Choicespine, LP | MAX | Class II | |
| K172716 | V2K Rinspiration System | V2k Medical, Inc. | QEW | Class II | |
| K171391 | Stryker 90-S Max SERFAS Energy Probe | Stryker Corp. | GEI | Class II | |
| K171367 | SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) | Sanrea Healthcare Products Pvt Ltd | LYY | Class I | |
| K162665 | MiCor A100 Wearable ECG Recorder | Mitac International Corp. | DPS | Class II | |
| K173581 | Gallant PTCA Dilatation Catheter | Medinol Ltd. | LOX | Class II | |
| K173542 | Arterys Oncology DL | Arterys Inc. | LLZ | Class II | |
| K173448 | CliniCloud Stethoscope | Stethocloud Pty.Ltd (Clinicloud) | DQD | Class II | |
| K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | V&Q Manufacturing Corporation | FXX | Class II | |
| K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | Fisher & Paykel Healthcare, Inc. | CBK | Class II | |
| K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corp. | HRX | Class II | |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer | Lite-On Technology Corp. H.S.P.B. | CJE | Class II | |
| K171968 | EchoGlo Needle | Abbott Medical | BSP | Class II | |
| K171954 | ClearLine IV | Clearline MD | OKL | Class II | |
| K171264 | Royal Flush Catheter | Cook Incorporated | DQO | Class II | |
| K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | EBZ | Class II | |
| K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | KWQ | Class II | |
| K173363 | Cycler Drain Bag Set | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | |
| K173196 | SUNTOUCH Dental Dressing | HuiZhou Foryou Medical Devices Co., Ltd. | OLR | Unclassified | |
| K171942 | Electrocardiograph | Edan Instruments, Inc. | DPS | Class II | |
| K171528 | Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) | Avantsonic Technology Co., Ltd. | IYO | Class II | |
| K173442 | gammaCore-S | Electrocore, Inc. | PKR | Class II | |
| K172304 | TruAbutment DS | TruAbutment Inc. | NHA | Class II | |
| K171789 | ARROW Reverse Porous Glenoid | Fournitures Hospitalieres Industrie | PHX | Class II | |
| K163684 | C2 CryoBalloon Ablation System | PENTAX of America, Inc. | GEH | Class II | |
| K180025 | Centurion POCT System | Orthofix SRL | NKG | Class II | |
| K173584 | 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader | 3M Company | FRC | Class II | |
| K173306 | EZ Plate | Zavation Medical Products, LLC | KWQ | Class II | |
| K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile | Scientia Vascular | DQX | Class II | |
| K173219 | Campylobacter Chek | Techlab, Inc. | LQP | Class I | |
| K173217 | Campylobacter Quik Chek | Techlab, Inc. | LQP | Class I | |
| K172920 | 3D Apt | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K171360 | CONTEC™ Electrocardiograph | Contec Medical Systems Co., Ltd. | DPS | Class II | |
| K171312 | FortiCore® | Nanovis, LLC | MAX | Class II | |
| K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | KCT | Class II | |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | Vascular Solutions LLC | KRD | Class II | |
| K173878 | PreXion3D Excelsior | Prexion Corporation | OAS | Class II | |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | Globus Medical, Inc. | JWH | Class II | |
| K173616 | DIP Arthrodesis System | In2Bones SAS | HTY | Class II | |
| K173554 | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope | PENTAX of America, Inc. | EOQ | Class II | |
| K173478 | OnSight 3D Extremity System | Eastman Kodak Company | JAK | Class II | |
| K173301 | BioSphere MIS Putty (BioSphere MIS) | Synergy Biomedical | MQV | Class II | |
| K173283 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | MAX | Class II | |
| K173215 | Choice Spine Laminoplasty™ Fixation System | Choicespine, LP | NQW | Class II |