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 |
|---|---|---|---|---|---|
| K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | Wuhan United Imaging Healthcare Co.,Ltd. | IYN | Class II | |
| K253642 | Jada System (Jada-2002) | Organon LLC | OQY | Class II | |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | |
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | CAH | Class II | |
| K252624 | KARL STORZ Laryngoscopes and Accessories | Karl Storz Endoscopy-America, Inc. | EQN | Class II | |
| K252563 | Neurophet SCALE PET | Neurophet, Inc. | QIH | Class II | |
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment(guangzhou) Co., Ltd. | FJK | Class II | |
| K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K250781 | Embryo Predict | Alife Health, Inc. | PBH | Class II | |
| K261317 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K261241 | TriMed Compression Screws | Trimed Inc | HWC | Class II | |
| K261224 | MatriDerm | MedSkin Solutions Dr. Suwelack AG | KGN | Unclassified | |
| K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, LLC | LRK | Class II | |
| K260892 | Suction Pump (SU-90) | Shenzhen Hugemed Medical Technical Development Co., Ltd | BTA | Class II | |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical Inc | EOQ | Class II | |
| K260485 | Any-Etch | Mediclus Co., Ltd | KLE | Class II | |
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | IYN | Class II | |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | IZL | Class II | |
| K254133 | ENTity USB Videoscope System | Optim LLC | EOB | Class II | |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical Inc | LLZ | Class II | |
| K253883 | Bonalive Maxillofacial | Bonalive Inc. | LYC | Class II | |
| K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | MRW | Unclassified | |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | NHA | Class II | |
| K253078 | Art.1-US | Seetreat Pty, Ltd. | MUJ | Class II | |
| K252776 | ARIES Anterior Cervical Plate Systems | Zhejiang Decans Medical Devices Co.,Ltd. | KWQ | Class II | |
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | Fortis Biosolutions Company Limited | DXT | Class II | |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) | Hunan Accurate Bio-Medical Technology Co., Ltd. | KPI | Class II | |
| K261363 | Y-Knotless™ Flex Anchors | ConMed Corporation | MBI | Class II | |
| K260032 | Morph | BeauBrain Healthcare, Inc. | QIH | Class II | |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd | HGX | Class II | |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | FRO | Unclassified | |
| K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | ITI | Class II | |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | IZI | Class II | |
| K253061 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc | QCF | Class II | |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | Acist Medical Systems, Inc. | DXT | Class II | |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | Acist Medical Systems, Inc. | DXT | Class II | |
| K252591 | Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics | QAI | Class II | |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co.,Ltd. | KNW | Class II | |
| K260850 | Osteomni Spinal Cages System | Osteomni Inc | ODP | Class II | |
| K260837 | VersaLift Expandable System | Life Spine | MAX | Class II | |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis de Mexico, S.A.P.I. de C.V. | FYA | Class II | |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | Shenzhen Kingboom Technology Co., Ltd | BTA | Class II | |
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | OHS | Class II | |
| K260378 | Rayvolve | AZmed | QBS | Class II | |
| K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | PZM | Class II | |
| K260051 | CorVision® (91-205-Z0014) | Corvent Medical Inc. | MOD | Class II | |
| K254192 | Senhance Ultrasonic System | Asensus Surgical, Inc. | NAY | Class II | |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | DZE | Class II | |
| K261214 | Pico Shining (Pico-K; Picofy) | Speclipse, Inc. | GEX | Class II |