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 |
|---|---|---|---|---|---|
| K251964 | Mimics Thoracic Planner | Materialise N.V. | LLZ | Class II | |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | CBK | Class II | |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | MBI | Class II | |
| K251584 | Medical Mesh Nebulizer (AirICU Max+) | Airicu Inc. | SFP | Class II | |
| K250794 | InVera Infusion Device | Invera Medical | KRA | Class II | |
| K250655 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | QZF | Class II | |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical Inc | DTZ | Class II | |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer GmbH | EBF | Class II | |
| K254197 | Picasso Pro Diode Laser (002-00460) | Cao Group, Inc. | GEX | Class II | |
| K254047 | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | Shenzhen Chuangtong Yigou Technology Co., Ltd | OHT | Class II | |
| K253986 | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | NAY | Class II | |
| K253906 | Xpert Hand | Newclip Technics | HRS | Class II | |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | MBI | Class II | |
| K253624 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | PHX | Class II | |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Eastman Kodak Company | IZL | Class II | |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | FRO | Unclassified | |
| K250937 | Venous Return Cannulae | LivaNova USA, Inc. | DWF | Class II | |
| K260773 | Varios Combi Pro2 | Nakanishi Inc. | ELC | Class II | |
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical | NVK | Class II | |
| K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K254093 | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | Synthes GmbH | HRS | Class II | |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | EIH | Class II | |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | OWB | Class II | |
| K253517 | Reselute Tibial Nail | Reselute | HSB | Class II | |
| K252353 | myray ProXIma X6 | Cefla S.C. | OAS | Class II | |
| K252168 | Straumann® BLC Implants - Indication Widening | Straumann USA, LLC | DZE | Class II | |
| K260405 | FiberTape Button | Arthrex GmbH | MBI | Class II | |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC | NFT | Class II | |
| K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | Synthes GmbH | HRS | Class II | |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | Qiagen | PCH | Class II | |
| K253960 | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | PDZ | Class II | |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K253413 | LiverMultiScan (v6.0) | Perspectum Ltd. | LNH | Class II | |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer GmbH | MBH | Class II | |
| K252888 | NeoSculpt Plus | S&M Medical Inc. | PBX | Class II | |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | FUJIFILM Corporation | FDT | Class II | |
| K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | OLZ | Class II | |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | HWC | Class II | |
| K260167 | Bunkerhill Contrast AVC | Bunkerhill Health | JAK | Class II | |
| K260166 | Bunkerhill Contrast CAC | Bunkerhill Health | JAK | Class II | |
| K260013 | CVAC Image Processor | Calyxo, Inc. | FGB | Class II | |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | NUC | Class II | |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | |
| K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | HBB | Class II | |
| K253551 | VELYS™ Hip Navigation | Depuy Ireland UC | QIH | Class II | |
| K253538 | TeKBrace Knotless Anchor | Theramicro | MBI | Class II | |
| K253262 | EmeryGlide™ (EG18008901) | NANO4IMAGING GmbH | DQX | Class II | |
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FGE | Class II | |
| K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | HIB | Class II | |
| K251818 | Bontree Plus | Hudens Bio Co., Ltd. | LYC | Class II |