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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K083821 | Vital Signs Monitor | Edan Instruments, Inc. | DQA | Class II | |
| K083648 | Gotfried Physiological Hip (Ph) Nail | Efratgo, Ltd. HI Tech Bio-Surgical | HSB | Class II | |
| K083385 | Mass Casualty Ventilators, Models: Mcv200 and Mcv200-B | Allied Medical LLC | BTL | Class II | |
| K083184 | Tearlab Osmolarity System | Ocusense, Inc. | OND | Class I | |
| K081130 | Bridgepoint Medical Crossboss Percutaneous Coronary Catheter | Boston Scientific Corporation | DQY | Class II | |
| K080868 | Aongen Collagen Matrix | Aeon Astron Europe B.V. | KGN | Unclassified | |
| K091169 | Elite Mpx Laser System with Cryo C | Cynosure, LLC | GEX | Class II | |
| K091040 | Microlife Digital Infrared Ear Thermometer, Model Iridvi-1 | Microlife Intellectual Property GmbH | FLL | Class II | |
| K081803 | St. Jude Medical Epicardial Catheter System | Abbott Medical | DRF | Class II | |
| K091261 | Nmi Picc | Boston Scientific Corporation | LJS | Class II | |
| K091042 | Crono S-Pid 50 | Cane S.r.l. | FRN | Class II | |
| K090833 | Segment | Medviso AB | LLZ | Class II | |
| K090354 | Laminoplasty Plating System | Aesculap Implant System, Inc. | NQW | Class II | |
| K090187 | Fora G30 Blood Glucose Monitoring System, Model Td-4241 | Taidoc Technology Corporation | NBW | Class II | |
| K083838 | Scaleman Body Fat Scales, Model: Fs-148Bw1 Series | Fook Tin Technologies Limited | MNW | Class II | |
| K083214 | Amplatzer Torqvue 45Degreex45degree Delivery Sheath, Models 9-Tv45x45-09F-100, 9-Tv45x45-10F-100 | Abbott Medical | DQY | Class II | |
| K091113 | Maxima V, Three Wheel Scooter, Model Sc900v Maxima V, Four Wheel Scooter, Model Sc940v | Pride Mobility Products Corp | INI | Class II | |
| K091043 | Power Drive Chair, Model: Tmm6 | Champion Mfg, Inc. | INK | Class II | |
| K090826 | Monobond Plus | Ivoclar Vivadent, Inc. | KLE | Class II | |
| K090601 | Fsc 2 | Schoelly Imaging, Inc. | NTN | Class II | |
| K090391 | Pulpdent Micro-Hybrid Composite | Pulpdent Corporation | EBF | Class II | |
| K090092 | Sockit! and Mcmerlin Dermal Wound Gel | Mcmerlin Dental Products LP | FRO | Unclassified | |
| K083102 | Refine Lift System | Alure Medical, Inc. | FTL | Class II | |
| K082686 | Multi-Channel Laser Therapy System | United Integrated Services Co., Ltd. | ILY | Class II | |
| K091269 | Neuropet | Photodetection Systems, Inc. | KPS | Class II | |
| K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle System | Medi-Globe GmbH | FCG | Class II | |
| K091175 | Grind No More Version 2 and 3 | Ranir, LLC | OBR | Unclassified | |
| K091131 | Pelvic Floor Repair System | Boston Scientific Corporation | OTP | Class III | |
| K091071 | Nuvasive Lateral Plate System | NuVasive Inc | KWQ | Class II | |
| K091068 | Accutorr V Monitor, Model 0998-00-2000 | Datascope Corp., Patient Monitoring Division | DXN | Class II | |
| K090864 | Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator System | Integra Radionics, Inc. | LFL | Unclassified | |
| K090717 | Flex-TENS | Emsi | GZJ | Class II | |
| K090692 | Ortholoc 2.0/2.4 Plate System | Wrightmedicaltechnologyinc | HRS | Class II | |
| K090683 | Syngo Rt Therapist Connect | Siemens Medical Solutions USA, Inc. | IYE | Class II | |
| K090513 | Vinyl Examination Glove, Powder Free Clear (Non-Colored) | Shandong Huayue Glove Co., Ltd. | LYZ | Class I | |
| K090409 | Bioplex 2200 Hsv-1 and Hsv-2 Igg on the Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories Inc. | MXJ | Class II | |
| K090363 | Zio Patch, Model Z100 | iRhythm Technologies, Inc. | DSH | Class II | |
| K090338 | Ultra Low Total Chlorine, E-Z Chek Sensitive Total Chlorine | Reprocessing Products Corp | MSY | Class II | |
| K090243 | Remstar M-Series Auto with Aflex CPAP System | Respironics Inc., Sleep & Home Respiratory Group | BZD | Class II | |
| K090078 | Kerasys Bioengineered Lamellar Patch Graft | Iop, Inc. | NXM | Class II | |
| K083844 | Advia Centaur Tsh3-Ultra Method | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. Pc-R Control Plasma and Biophen | Aniara Diagnostica LLC | GGW | Class II | |
| K083499 | Exair Anterior and Posterior Prolapse Repair Systems | MEDLINE INDUSTRIES, LP - Northfield | OTP | Class III | |
| K083156 | Non Sterile Powder Free Nitrile Examination Gloves, Blue | Giga-Drive Sdn, Bhd | LZA | Class I | |
| K082474 | Pmt Subdural Cortical Electrodes | PMT Corp. | GYC | Class II | |
| K082060 | Cranial Image Guided Surgery System | Brainlab, Inc. | HAW | Class II | |
| K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone Sp1, Model M3634 | Agilent Technologies, Inc. | MYA | Class II | |
| K091152 | Virtue Ventral Urethral Elevation Sling System, Model 50020 | MEDLINE INDUSTRIES, LP - Northfield | OTM | Class II | |
| K090691 | Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Shijiazhuang Benestar Plastic Co., Ltd. | LYZ | Class I | |
| K090677 | Innoport Laparoscopic Access Device | Innovia, LLC | GCJ | Class II |