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 |
|---|---|---|---|---|---|
| K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | FCX | Class II | |
| K240670 | DRI Ecstasy Plus Assay | Microgenics Corporation | DKZ | Class II | |
| K240560 | ZENEX Implant System_Long | Izenimplant Co., Ltd. | DZE | Class II | |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) | Lagis Enterprise Co., Ltd. | GCJ | Class II | |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | FLL | Class II | |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | DSI | Class II | |
| DEN230082 | Stone Clear (SC-LP9-01) | Sonomotion, Inc. | QNA | Class II | |
| K243247 | Persona the Personalized Knee System | Zimmer GmbH | MBH | Class II | |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K243157 | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | GXH | Class II | |
| K243126 | Tracheobronxane™ Dumon® | Novatech S.A. | NWA | Class II | |
| K243095 | Mammotome AutoCore™ Single Insertion Core Biopsy System | Devicor Medical Products Inc | KNW | Class II | |
| K243080 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | Qiagen | PLO | Class II | |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems, Inc. | JAQ | Class II | |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | |
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | DEHAS Medical Systems GmbH | CBP | Class II | |
| K241189 | Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) | Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd. | ITI | Class II | |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | OVD | Class II | |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | Tigon Medical LLC | HWC | Class II | |
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | NQW | Class II | |
| K242622 | Sterile Lancets for Single Use | Ningbo Caremed Medical Products Co Ltd | QRK | Class II | |
| K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions | NKB | Class II | |
| K241992 | Catalyft™ LS Expandable Interbody System | Medtronic Sofamor Danek USA Inc | OVD | Class II | |
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | OHS | Class II | |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech Inc. | QKQ | Class II | |
| K243189 | TumorSight Viz | Simbiosys, Inc. | QIH | Class II | |
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | OYK | Class II | |
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | OYK | Class II | |
| K243070 | Xpert® SA Nasal Complete | Cepheid | NQX | Class II | |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K243030 | Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) | Ulike Co., Ltd. | OHT | Class II | |
| K242984 | BKS Revision System | Ortho Development Corp. | JWH | Class II | |
| K242969 | Pantera Pro; Pantera LEO | BIOTRONIK AG | LOX | Class II | |
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | Ocuject, LLC | QNS | Class II | |
| K242625 | Freeze Point & Private Label Versions | Cryoconcepts LP | GEH | Class II | |
| K242397 | LYNX Photocoagulator | Norlase ApS | HQF | Class II | |
| K242353 | QIAstat-Dx Respiratory Panel Mini | Qiagen | QOF | Class II | |
| K242215 | Neurophet AQUA (V3.1) | Neurophet, Inc. | QIH | Class II | |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Halyard Health | KNT | Class II | |
| K240918 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism | Bruno Vision Care, LLC | LPL | Class II | |
| K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) | Comfort Rubber Gloves Industries Sdn Bhd | LZA | Class I | |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal ve Tibbi Cihazlar Dis Ticaret Limited Sirketi | FLL | Class II | |
| K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) | Shenzhen Yimi Life Technology Co.,Ltd | DQA | Class II | |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | Vatech Co., Ltd. | MUH | Class II | |
| DEN230084 | Dexter L6 System | Distalmotion SA | SDD | Class II | |
| K242560 | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co.,Ltd | IOR | Class I | |
| K242512 | ROCC Console | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona Inc | EIH | Class II |