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 |
|---|---|---|---|---|---|
| K162625 | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters | B. BRAUN INTERVENTIONAL SYSTEMS Inc. | LOX | Class II | |
| K161354 | MELODY, Remote Control System for Ultrasound Probe | Adecho Tech | IYO | Class II | |
| K171420 | 1717SCC_127um and 1717SCC_140um | Rayence Co., Ltd. | MQB | Class II | |
| K171419 | 1717SGC_127um and 1717SGC_140um | Rayence Co., Ltd. | MQB | Class II | |
| K170996 | Wingman 14C Crossing Catheter | ReFlow Medical, Inc | DQY | Class II | |
| K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II | |
| K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | FYA | Class II | |
| K170747 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K170730 | JAZZ System, including JAZZ Band | Implanet | OWI | Class II | |
| K170515 | Sterile Nitrile Surgical Gloves, Powder-free | Primus Gloves Pvt Limited | KGO | Class I | |
| K170169 | PRECICE Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K163652 | ePlex Instrument | Genmark Diagnostics, Incorporated | NSU | Class II | |
| K163636 | ePlex Respiratory Pathogen Panel | Genmark Diagnostics, Incorporated | OCC | Class II | |
| K163475 | iVue | Optovue Inc. | OBO | Class II | |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K162685 | 2-Piece Hammertoe Correction System | Life Spine | HWC | Class II | |
| K162569 | YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer | Biotech Lubricants, Ltd. | NUC | Class II | |
| K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | FMF | Class II | |
| K171256 | Quingo Flyte Mobility Scooter | Agile Distributors, LLC | INI | Class II | |
| K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | LLZ | Class II | |
| K171112 | Trifore(tm) Cervical Plating System | Neurostructures, Inc. | KWQ | Class II | |
| K171086 | Accuray Precision Treatment Planning System | Accuray Incorporated | IYE | Class II | |
| K171066 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Medtronic, Inc. | GEI | Class II | |
| K170967 | Intraskan DC Plus | Skanray Technologies Private Limited | EHD | Class II | |
| K170961 | NuVasive CoRoent Small Interlock II System | Nu Vasive, Incorporated | OVE | Class II | |
| K170821 | ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System | Choicespine, LP | NKB | Class II | |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | ACell, Inc | FTM | Class II | |
| K170681 | Continuous Single Culture -NX (CSCM-NX) | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K170661 | Novosyn Quick Absorbable Suture | Aesculap Inc | GAM | Class II | |
| K170460 | Sorin Connect | LivaNova Deutschland GmbH | DXJ | Class II | |
| K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals LLC | GEX | Class II | |
| K170101 | Valiant Curing Light | Inter-Med/Vista Dental Products | EBZ | Class II | |
| K163580 | ASD Oral Appliances | American Sleep Dentistry | LRK | Class II | |
| K163193 | UTF Stem, reduced, #0, #00 | United Orthopedic Corp. | LPH | Class II | |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | Smith & Nephew, Inc. | HTN | Class II | |
| K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | HIR | Class II | |
| K162610 | NEXA Negative Pressure Wound Therapy System | Nexa Medical, Ltd. | OMP | Class II | |
| K161327 | Syntec Humeral Nail System | Syntec Scientific Corp. | HSB | Class II | |
| K171357 | SurgiMend PRS Meshed, Revize-X | Integra Lifesciences Corporation (Owner of Tei Biosciences) | OXH | Class II | |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray Inc | IZL | Class II | |
| K171335 | Venture 038 catheter | Vascular Solutions LLC | DQY | Class II | |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | LXB | Class II | |
| K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray Systems, Inc. | IYE | Class II | |
| K170736 | HySil Impression Materials | OSSTEM Implant Co., Ltd. | ELW | Class II | |
| K170728 | E. Histolytica Quik Chek | Techlab, Inc. | KHW | Class II | |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX | Toshibamedical Systems Corporation | LNH | Class II | |
| K170356 | Straumann Variobase Abutments | Straumann USA, LLC | NHA | Class II | |
| K170354 | Straumann Variobase Abutments | Straumann USA, LLC | NHA | Class II |