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 |
|---|---|---|---|---|---|
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra LifeSciences Production Corporation | JXG | Class II | |
| K233226 | FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC | LLZ | Class II | |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | KNW | Class II | |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co.,Ltd. | LDJ | Class II | |
| K231871 | Radify Triage | Envisionit Deepai, Ltd. | QFM | Class II | |
| K231135 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | |
| K233970 | Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC | LZA | Class I | |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | Sterilance Medical (Suzhou) Inc. | FMK | Class II | |
| K233512 | Rapid (6.0) | Ischemaview, Inc. | QIH | Class II | |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. | QGL | Class II | |
| K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | GAP | Class II | |
| K232062 | Uni-port | Dalim Medical Corp. | OTJ | Class II | |
| K231144 | Washtrays | Dentsply Sirona Inc | KCT | Class II | |
| K231138 | Aniti-Snore Mouthguard+ | Oscimed SA | LRK | Class II | |
| K223266 | Hilzo Esophageal Stents | Thoracent LLC | ESW | Class II | |
| K223234 | Delta4 Insight | Scandidos, Inc. | IYE | Class II | |
| K233216 | CLEWICU System | Clew Medical, Ltd. | QNL | Class II | |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | JEY | Class II | |
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K233677 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K233520 | Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Anhui Powerguard Technology Co., Ltd. | LZA | Class I | |
| K233355 | Cypris eXact Suturing System | Cypris Medical, Inc. | GAW | Class II | |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro Inc. | HAW | Class II | |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro Inc. | HAW | Class II | |
| K233141 | SmartFrame OR | ClearPoint Neuro Inc. | HAW | Class II | |
| K233125 | Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd | EIH | Class II | |
| K233114 | LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) | Shenzhen Idea Light Limited | OHS | Class II | |
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | Owens & Minor (O&M) Halyard, Inc. | MSH | Class II | |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | HIF | Class II | |
| K232990 | A’TOMIC™ Nitinol Fixation System | RMR ORTHO, Inc | JDR | Class II | |
| K232970 | Hem-o-lok® Ligating Clips | Teleflex Medical | FZP | Class II | |
| K232615 | LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) | Devicor Medical Products Inc | NEU | Class II | |
| K232170 | Ti Link Abutment | Izenimplant Co., Ltd. | NHA | Class II | |
| K232032 | Probeat-Fr | Hitachi High-Tech Corp., Kashiwanoha | LHN | Class II | |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | PENTAX of America, Inc. | EOQ | Class II | |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | QOG | Class II | |
| K231684 | Quick - Radius Disposable Set | GM dos Reis Industria e Comercio Ltda | HRS | Class II | |
| K231558 | SMB Luer lock disposable syringe | SMB Corporation of India | FMF | Class II | |
| K231371 | BEE Cervical Cage | Ngmedical GmbH | ODP | Class II | |
| K231315 | Velox Power Chair | Velox Manufacturing Inc. | ITI | Class II | |
| K222783 | MD Mattress Suture Placement Device | Lsi Solutions Inc. | GCJ | Class II | |
| DEN230015 | Osteoboost Belt | Bone Health Technologies | QZO | Class II | |
| DEN230008 | DermaSensor | Dermasensor Inc | QZS | Class II | |
| DEN220040 | Fibresolve | Imvaria | QWO | Class II | |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems DMC GmbH | JAA | Class II | |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.p.A. | MBF | Class II | |
| K233664 | IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | PNN | Class II | |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe | Shenzhen Roundwhale Technology Co. Ltd. | GXY | Class II |