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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K150473 | FlexPointer 1.5 mm | Fiagon GmbH | PGW | Class II | |
| K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs | Integra LifeSciences Corporation | HAE | Class II | |
| K150326 | PicoWay Laser System | Candela Corporation | GEX | Class II | |
| K143592 | Gamma Phage Lysis Assay for the Identification of Bacillus Anthrac | The Surgeon General, Department of the Army | NVQ | Class II | |
| K143536 | Voyant Fine Fusion Device | Applied Medical Resources Corp | GEI | Class II | |
| K143506 | Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes; Bis Quatro Sensor; Bis Pedi-Xp Sensor,2-Channel (4 Electrodes); Bis Extend Sensor; Bis Bilateral Sensor,4-Channel (6 Elecrodes); Bis Insight Sensor,cvi-Enabled,2-Channel (4 Electrodes) | Medtronic, Inc. | GXY | Class II | |
| K143416 | SOMATOM Definition Flash (VA48) | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | Rex Medical LP | DTK | Class II | |
| K142551 | QANS (Quantitative Autonomic Nervous System) Monitoring System | Hhssystems, LLC | DPS | Class II | |
| K141880 | Biopor Aoc Porous Polyethylene, Cerepor | Ceremed, Inc. | KKY | Class II | |
| K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials | Abbott Medical | DHA | Class II | |
| K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) | I-See Vision Technology, Inc. | LPL | Class II | |
| K143591 | Dorsal Appliance | Gergens Orthodontic Lab | LRK | Class II | |
| K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing LLC | KCT | Class II | |
| K141914 | Prodigy Autocode Eject Blood Glucose Monitoring System | OK Biotech Co., Ltd. | NBW | Class II | |
| K141888 | Rusch Endobronchial Tubes | Teleflexmedical, Inc. | CBI | Class II | |
| K150746 | JUSHA-M52C Medical Display | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K150083 | Sidecar External Working Channel | PENTAX of America, Inc. | FED | Class II | |
| K150072 | TheyFit Male Condom | Theyfit | HIS | Class II | |
| K143744 | MicroCross Catheter | Roxwood Medical, Inc. | DQY | Class II | |
| K143731 | IMPLANET Spine System (ISS) | Implanet | NKB | Class II | |
| K143664 | HeartSee | University of Texas Medical School at Houston | KPS | Class II | |
| K143333 | Revital-Ox RESERT Solution Test Strip | STERIS Corporation | JOJ | Class II | |
| K143332 | Fast Sphyg by Koven | Koven Technology, Inc. | DXQ | Class II | |
| K143269 | Delivery Analysis | Accuray Incorporated | MUJ | Class II | |
| K143265 | Acrylic Block | Sun Medical Co., Ltd. | EBI | Class II | |
| K142824 | LX-100 Hair Growth Stimulation System | Hairlabs International, Inc. | OAP | Class II | |
| K141324 | Hongyu Disposable Surgical Drapes | Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | KKX | Class II | |
| K141047 | Lc Calciumhydroxide Liner | S&C Polymer Silicon- und Composite Spezialitaeten | EJK | Class II | |
| K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II | |
| K150705 | FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator | Minimally Invasive Devices, LLC | GCJ | Class II | |
| K150516 | Deka Synchro Repla:y Family of Laser Systems | El.en. Electronic Engineering SpA | GEX | Class II | |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K150065 | SoundCure Serenade Tinnitus Treatment System | Soundcure, Inc. | KLW | Class II | |
| K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | NPK | Class II | |
| K143241 | MDT Navigable Brain Biopsy Cannula | Izi Medical Products LLC | HAW | Class II | |
| K142687 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | DQA | Class II | |
| K142647 | mint Lesion | Mint Medical GmbH | LLZ | Class II | |
| K142473 | Lubricating Jelly | Sion Biotext Medical Ltd | KMJ | Class I | |
| K142445 | Pinpoint Gt Safety Introducer Needle | C.R. Bard Inc | DYB | Class II | |
| K142208 | Monopolar Laparascopic Accessories | Unimicro Medical Systems (Shenzhen) Co., Ltd. | GEI | Class II | |
| K150821 | MDNG-3220 (Nio 3MP LED) | Barco N.V. | PGY | Class II | |
| K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | LHQ | Class I | |
| K150302 | PROFEMUR Preserve Classic Stem | Microport Orthopedics Inc. | LZO | Class II | |
| K150204 | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K143706 | FortiBridge Anterior Cervical Plate System | Nanovis Spine, LLC | KWQ | Class II | |
| K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | MUD | Class II | |
| K142911 | ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Huailai ZM Plastic Products Co., Ltd. | LYZ | Class I | |
| K142456 | GPS Spacers | G Surgical Co., Ltd. | ODP | Class II | |
| K142262 | Aution Check Plus | Quantimetrix Corp. | JJW | Class I |