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 |
|---|---|---|---|---|---|
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. | KGE | Class II | |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | JAK | Class II | |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28 | HSB | Class II | |
| K253442 | EarliPoint Assessment | Earlitec Diagnostics | QPF | Class II | |
| K253267 | CORIS System | Nanosonics Limited | SEW | Class II | |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | |
| K252538 | Cephx3d | Orca Dental AI | QIH | Class II | |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | KLE | Class II | |
| K252196 | Arthrex FibuLock Nail System | Arthrex GmbH | HSB | Class II | |
| K251901 | Magnifico Open (100009900) | Esaote S.p.A. | LNH | Class II | |
| K251788 | Extension tube | Zhuhai Dr Medical Instruments Co., Ltd. | DXT | Class II | |
| K260380 | Mendit | Escala Medical | PBQ | Class II | |
| K260365 | Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products Inc | KNW | Class II | |
| K260015 | ANTERIS Thoracolumbar Plate System | Spinecraft LLC | KWQ | Class II | |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | MBI | Class II | |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | IYO | Class II | |
| K253896 | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd | NUH | Class II | |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OLP | Class II | |
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | FTC | Class II | |
| K253870 | Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd. | ITI | Class II | |
| K253565 | SureSmile Software | Dentsply Sirona Inc | PNN | Class II | |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co.,Ltd | DZE | Class II | |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | HSB | Class II | |
| K251434 | Healing Abutment System | OSSTEM Implant Co., Ltd. | NHA | Class II | |
| DEN250012 | LifeVac | LifeVac, LLC | QXN | Class II | |
| K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Co | KLE | Class II | |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex GmbH | HRS | Class II | |
| K260010 | TMINI® Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K254245 | Zafira® | New Stetic | EBF | Class II | |
| K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd | GEX | Class II | |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | OHS | Class II | |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte., Ltd. | LRK | Class II | |
| K253818 | Annalise Enterprise | Harrison-AI Medical Pty Ltd | QAS | Class II | |
| K252534 | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | FXX | Class II | |
| K251940 | PathLoc Lumbar Plate System | L&K Biomed Co.,Ltd. | KWQ | Class II | |
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corporation | MUH | Class II | |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & Co. KG | EWY | Class II | |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K254054 | VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System | Synthes GmbH | HRS | Class II | |
| K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | MQC | Unclassified | |
| K253771 | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) | Nanjing Devin Medical Technology Co., Ltd. | NEY | Class II | |
| K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp | QIH | Class II | |
| K253380 | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co.,Ltd | EBG | Class II | |
| K252632 | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | NEY | Class II | |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Corp. Pty. Ltd. | LRK | Class II | |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus ACMI, Inc. | GEI | Class II | |
| K251777 | MESI mTABLET SPIRO | Mesi d.o.o. | BZG | Class II | |
| K260292 | Hotwire RF Guidewire (901Xxx); Hotwire RF Guidewire (902Xxx) | Atraverse Medical | DXF | Class II | |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | HRS | Class II | |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing Huacheng Taike Technology Co., Ltd. | GEX | Class II |