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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180726 | Savion DLVR Guidewire, Savion FLX Guidewire | Boston Scientific Corporation | DQX | Class II | |
| K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard Inc | LJS | Class II | |
| K172895 | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 | Ageless Health Industrial Co., Ltd. | DXN | Class II | |
| K172842 | GCE704 Breast Pump | Globalcare | HGX | Class II | |
| K172345 | IU Implant System | WARANTEC Co., Ltd. | DZE | Class II | |
| K181325 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | |
| K181290 | Fusion Bx 2.0 | Focal Healthcare Inc. | LLZ | Class II | |
| K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | HRS | Class II | |
| K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine | OUR | Class II | |
| K180497 | Scone Mask | ResMed Corp | BZD | Class II | |
| K173936 | Natus Photic Stimulator | Natus Medical Incorporated | GWE | Class II | |
| K173908 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | Philips Healthcare (Suzhou) Co., Ltd. | LNH | Class II | |
| K173225 | Interlude and private label Unscented 3-piece compact applicator tampon | Albaad Fem | HEB | Class II | |
| K172954 | Medline Prevention CoolZone Gown | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K172551 | Trinity PLUS Acetabular Shell | Corin USA | LPH | Class II | |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE | Hightech Development | EGJ | Class II | |
| K181351 | Double Flexible Tipped Wire Guides | Cook Incorporated | DQX | Class II | |
| K181316 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | NBW | Class II | |
| K181301 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | JXG | Class II | |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Arthrosurface, Inc. | KRR | Class II | |
| K180813 | Btl 799-2 | BTL Industries, Inc | NGX | Class II | |
| K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter | Compactcath, Inc | EZD | Class II | |
| K180719 | InMode Diolaze System | Inmode MD, Ltd. | GEX | Class II | |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) | Hartalega Sdn Bhd | LZA | Class I | |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | Renovis Surgical Technologies, LLC | OVD | Class II | |
| K180401 | TiWAVE-C™ Porous Titanium Cervical Cage | Kalitec Direct, LLC | ODP | Class II | |
| K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated | GWQ | Class II | |
| K180100 | MRIaudio PREM System | Mriaudio, Inc. | LNH | Class II | |
| K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | Biosense Webster Inc | DQK | Class II | |
| K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | LLZ | Class II | |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | KWY | Class II | |
| K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | GMQ | Class II | |
| K172985 | Ligation Device | Leo Medical Co., Ltd. | FHN | Class II | |
| K172938 | Disposable Sterile Needle | Jiangsu Caina Medical Co., Ltd | FMI | Class II | |
| K172800 | Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors | Abbott Medical | MIA | Class II | |
| K172787 | Access hsTnl | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) | Hmicro, Inc. | DRG | Class II | |
| K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | OWP | Class II | |
| K181429 | CELERITY 20 HP Biological Indicator | STERIS Corporation | FRC | Class II | |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | MUI | Class II | |
| K181298 | Harmony XL Multi-Application Platform | Alma Lasers Ltd. | ONF | Class II | |
| K181279 | Ysio Max | Siemens Medi Cal Solutions, Inc. | KPR | Class II | |
| K181271 | Signature Orthodontic System | Signature Orthodontics | NJM | Class II | |
| K181050 | Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Qualimed SRL | LPL | Class II | |
| K180989 | PEDRA-17F Digital Flat Panel X-ray Detector | Radisen Co Ltd | MQB | Class II | |
| K180861 | Vinyl Examination Glove (Clear, Non-Colored) | Zhicheng Trading Co., Ltd. | LYZ | Class I | |
| K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | Tenon Medical, Inc. | OUR | Class II | |
| K180681 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | LSL | Class II | |
| K180675 | Atlas Spine Expandable Cervical Interbody System | Atlas Spine, Inc. | ODP | Class II |