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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K252739 | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | FMF | Class II | |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | DYB | Class II | |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | Abbott Medical | DQY | Class II | |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | FOZ | Class II | |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | HRS | Class II | |
| K251416 | UltraSight Guidance | Ultrasight | QJU | Class II | |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co., Ltd. | MHX | Class II | |
| K253620 | TroClose 1200 | Gordian Surgical | GAM | Class II | |
| K253118 | Companion Spine DIAM™ Instrumentation | Companion Spine France | QLR | Class II | |
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) | Polyconversions, Inc. | QPC | Class II | |
| K252919 | Identify (5.0) | Varian Medical Systems, Inc. | IYE | Class II | |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. | FGB | Class II | |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular | LJS | Class II | |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | CAW | Class II | |
| K252204 | prolaio eVO2peak Module (Version 1.0) | Prolaio Inc. | PPW | Class II | |
| K252111 | Versius Surgical System (Versius Plus) | CMR Surgical Inc. | SCV | Class II | |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co.,Ltd. | FGB | Class II | |
| K251893 | Skan C Pulsar | Skanray Technologies Limited | OWB | Class II | |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty Limited | HSX | Class II | |
| K251763 | IRISeg | Intuitive Surgical, Inc. | QIH | Class II | |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | DXQ | Class II | |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | PENTAX of America, Inc. | FDS | Class II | |
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics, Inc. | OVK | Class II | |
| K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc | DYB | Class II | |
| K253677 | Tembo Embolic System | Instylla, Inc. | KRD | Class II | |
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys Inc. | LKF | Class II | |
| K253101 | HyperVue™ Imaging System - Integrated | Spectrawave, Inc. | NQQ | Class II | |
| K252950 | Paradigm System | Proprio | OLO | Class II | |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd | NUC | Class II | |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., dba Stryker Orthopaedics | KRO | Class II | |
| K252675 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | OLI | Class II | |
| K251770 | SleepRes PAP System | Sleepres, Inc | BZD | Class II | |
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | OQB | Class II | |
| K250319 | Mfuse (Ms001) | Machina Medical Corporation | QSY | Unclassified | |
| K250851 | Hypnos (369054-200) | Cadwell Industries Inc | OLZ | Class II | |
| K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | HSB | Class II | |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon Inc | QSY | Unclassified | |
| K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc | LNH | Class II | |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | EMA | Class II | |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | Micro-Energy Medical Technology Co., Ltd. | GEX | Class II | |
| K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular Inc | KNW | Class II | |
| K252391 | Revi System | Bluewind Medical Ltd. | QXM | Class II | |
| K252273 | Therapy US | DMC Importacao e Exportacao de Equipamentos Ltda | NHN | Class II | |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | HKI | Class II | |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med Inc. | NEU | Class II | |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co.,Ltd | FRG | Class II | |
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | iHealth Labs, Inc. | SCA | Class II |