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 |
|---|---|---|---|---|---|
| K170414 | Arthrex Univers Revers Apex Humeral Stems | Arthrex GmbH | PHX | Class II | |
| K170389 | TAURUS PEEK Cage System | Medyssey USA | MAX | Class II | |
| K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | LIT | Class II | |
| K173524 | ANAX 5.5™ Spinal System | CG MedTech Co., Ltd. | NKB | Class II | |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | PSZ | Class II | |
| K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | OBP | Class II | |
| K173374 | TSV BellaTek Encode Healing Abutments | ZimVie US Corp LLC | NHA | Class II | |
| K173369 | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | IYN | Class II | |
| K173002 | 2940 nm Er:Yag Laser Handpiece | Quanta System Inc. | GEX | Class II | |
| K172932 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard Inc | OZT | Class II | |
| K172692 | Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens | TANGIBLE SCIENCE Inc | LPL | Class II | |
| K172651 | FMP Extended Liners | Encore Medical, LP | OQG | Class II | |
| K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath | Cook Incorporated | FED | Class II | |
| K172056 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | IYO | Class II | |
| K172052 | Arthrex DynaNite Nitinol Staple | Arthrex GmbH | JDR | Class II | |
| K171781 | eVox System | Evoke Neuroscience, Inc. | GWQ | Class II | |
| K171729 | Fixtemp C&B | Dreve Dentamid GmbH | EBG | Class II | |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | I-SENS, Inc. | NBW | Class II | |
| K171381 | Adhesive Electrodes | Shenzhen Quality Medical Technology Co.,Ltd | GXY | Class II | |
| K171167 | Prodigio Stain Powder | Operart, LLC | EIH | Class II | |
| K171058 | Medacta Shoulder System: Threaded Glenoid Baseplate | Medacta International SA | PHX | Class II | |
| K170790 | SAM CRRT Unit, SAM Cassette CRRT | Spectral Medical Inc. | KDI | Class II | |
| K173536 | T2Candida 1.1 Panel | T2biosystems, Inc. | PII | Class II | |
| K173467 | Advanced Diffusion Analysis (ADA) application | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K173392 | Pure-Vu System | MOTUS GI Medical Technologies Ltd. | FDF | Class II | |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | Hartalega Sdn Bhd | LZA | Class I | |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | LRC | Class I | |
| K172432 | SporView Rapid Read Biological Indicator | Crosstex/Spsmedical, A Division of Cantel Medical | FRC | Class II | |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | IYN | Class II | |
| K171956 | Sterile Endoscope Biopsy Sampling Needle | Changzhou Detain Medical Devices Co., Ltd. | FCG | Class II | |
| K170988 | DropSafe Safety Pen Needle | HTL-Strefa S.A. | FMI | Class II | |
| K170898 | Wittich Nitinol Stone Basket | Cook Incorporated | LQR | Class II | |
| K170279 | Disposable High Pressure Syringe | Union Medical Shenzhen Co., Ltd. | DXT | Class II | |
| K173612 | Optima XR646 HD | GE Hualun Medical Systems Co., Ltd. | KPR | Class II | |
| K173484 | CorticaLINK Spinal Fusion Platform | Linkspine, Inc. | NKB | Class II | |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb Incorporated | MSS | Class I | |
| K172405 | Sniper Staple System, Non-Sterile | Trilliant Surgical LLC | JDR | Class II | |
| K170276 | Safety Blood Collection Device for Single Use | Gemtier Medical (Shanghai) Inc. | FMI | Class II | |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | Euroimmun US Inc. | LSR | Class II | |
| K172713 | Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set | Fujirebio Diagnostics, Inc. | PRI | Class II | |
| K173475 | Merge PACS | Merge Healthcare Incorporated | LLZ | Class II | |
| K173462 | Wireless Pain Relieve Device Model: LT5018C | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | |
| K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | NKB | Class II | |
| K172966 | CMS-2000 Central Monitoring System | Advanced Instumentations, Inc. | MHX | Class II | |
| K172786 | MDS Plating System | Miami Device Solutions, LLC | HRS | Class II | |
| K172756 | Varian cage | Medyssey USA | MAX | Class II | |
| K172731 | VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) | bioMerieux, Inc. | LON | Class II | |
| K172714 | LipiVage | Genesis Biosystems Inc. | MUU | Class II | |
| K172445 | RoyalGuard Surgical Gown, i600, Breathable | Gri Medical & Electrical Technology Co., Ltd. | FYA | Class II | |
| K172302 | InMode PLUS System | Inmode MD, Ltd. | PBX | Class II |