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 |
|---|---|---|---|---|---|
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | Trimed Inc | HRS | Class II | |
| K250920 | Arthrex Spine Compression FT Screw | Arthrex GmbH | MRW | Unclassified | |
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic Inc | EZN | Class II | |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | HFN | Class II | |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | FLL | Class II | |
| K250639 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology Inc. | LZA | Class I | |
| K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | MQG | Class II | |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K242586 | ArgoCap (200.52) | Ovesco Endoscopy AG | OCX | Class II | |
| DEN240035 | ConcizuTrace™ ELISA | Randox Laboratories, Limited | SES | Class II | |
| K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc | LNH | Class II | |
| K251239 | GrandioSO Unlimited | Voco GmbH | EBF | Class II | |
| K251230 | The Alma Hybrid Laser System | Alma Lasers Ltd. | GEX | Class II | |
| K251109 | SMARTDent | Ray Co., Ltd. | LLZ | Class II | |
| K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | QJI | Class II | |
| K250528 | Stryker AlphaVent™ Knotless SP Biocomposite Anchor | Stryker Corp. | MAI | Class II | |
| K250493 | MotiliCap GI Monitoring System | Anx Robotica Corp. | NYV | Class II | |
| K243866 | InVision Precision Cardiac Amyloid | Invision Medical Technology | SDJ | Class II | |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K243762 | Synapse 3D Base Tools (V7.0) | FUJIFILM Corporation | QIH | Class II | |
| K243429 | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | GWG | Class II | |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | OXF | Class II | |
| K243122 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K243116 | FlareHawk Interbody Fusion System | Integrity Implants Inc. dba Accelus | MAX | Class II | |
| K242857 | ClearHemograsper | Finemedix | KGE | Class II | |
| K242637 | MEM Clear Aligner System | Mem Dental Technology Co Ltd | NXC | Class II | |
| K242527 | The Karma® Fixation System | Spinal Elements, Inc | MRW | Unclassified | |
| K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ | Abbott Medical | OBJ | Class II | |
| K250866 | Sovereign Posterior Cervical System | Met One Technologies, LLC | NKG | Class II | |
| K250602 | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | KWQ | Class II | |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd | EIH | Class II | |
| K250489 | Fp3d | Keystone Industries | EBI | Class II | |
| K250370 | SCENARIA View Phase 5.0 | FUJIFILM Corporation | JAK | Class II | |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | Flexicare Medical Ltd. | BTR | Class II | |
| K250199 | VitalFlow Console | Medtronic, Inc. | QNR | Class II | |
| K242485 | EveryWare | Breas Medical AB | MOD | Class II | |
| K250456 | Dentemp Pro-Comfort Dental Guard | Doc Brands, Inc. | OBR | Unclassified | |
| K250447 | BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton Dickinson & Co | LON | Class II | |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals Inc. | LFD | Unclassified | |
| K250122 | SleepRight Snore Aid | Splintek Inc. | LRK | Class II | |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd | NGX | Class II | |
| K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | restor3d, Inc. | PHX | Class II | |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Head Quarters | NRY | Class II | |
| K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | OWB | Class II | |
| K243301 | MapRT | Vision Rt Inc | IYE | Class II | |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company Ltd. | ILY | Class II | |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | ResMed Corp | BZD | Class II |