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 |
|---|---|---|---|---|---|
| K900880 | Olympus Jf-Um3-7.5/-12 and Cf-Um3-7.5/-12 | Olympus Corp. | ITX | Class II | |
| K900745 | Vs-200S Jet Ventilator | Acutronic Medical Systems AG | CBK | Class II | |
| K900744 | Ams 3000 Portable Jet Ventilator | Acutronic Medical Systems AG | CBK | Class II | |
| K910973 | Disposable Irrigating/aspirating Handpiece | Surgical Technologies, Inc. | HQE | Class II | |
| K910597 | Sunglasses Model #Sp Promo #1 and Sp Promo #2 | Radix Group Intl. | HQY | Class I | |
| K910490 | Modified Monitoring System Models M1175a & M1176a | Hewlett-Packard Co. | DSI | Class II | |
| K910372 | Intimax Thrombectomy Catheter | Applied Vascular Devices, Inc. | DXE | Class II | |
| K905520 | Microtrapper/microdigitrapper, Modification | Synectics-Dantec | BZQ | Class II | |
| K905449 | Electrosonogram Esg-1 | Myo-Tronics, Inc. | NFQ | Class I | |
| K904943 | Tapscope Esophageal Cardiac Recording Stethoscope | Arzco Medical Electronics, Inc. | BZT | Class II | |
| K902859 | Servo Ventilator 300 | Siemens Life Support Systems | CBK | Class II | |
| K900366 | Arrhythmia 9215 | S & W Medico Teknik | DSI | Class II | |
| K911694 | Patient Examination Latex Gloves (Non-Sterile) | Guthrie Medicare Products (Melaka) Sdn Bhd | LYY | Class I | |
| K911493 | Laparoscopic Irrigation Pump | United States Endoscopy Group, Inc. | GCJ | Class II | |
| K911486 | Laparoscopic Suction/irrigation Cannula | United States Endoscopy Group, Inc. | GCJ | Class II | |
| K911461 | Surgitron | Ellman Intl. Mfg., Inc. | GCI | Class II | |
| K911411 | Bard 3000 Plus Ureteroscopy System | C.R. Bard Inc | FGB | Class II | |
| K911258 | Kendall Pediatric Urine Meter | Kendall Healthcare Products Co. Div.Of Tyco Health | EXR | Class II | |
| K911245 | Eudermic Surgical Gloves | BD Becton Dickinson Vacutainer Systems Preanalytic | KGO | Class I | |
| K911242 | Kendall Pediatric Ultramer Polyurethane Catheter | Kendall Healthcare Products Co. Div.Of Tyco Health | KOD | Class II | |
| K911189 | Sterile Polypropylene Monfil Nonabsorb Surg Suture | Internacional Farmaceutica, S.A. de C.V. | GAW | Class II | |
| K911157 | Applicator Loop Sutures | Northgate Technologies Inc. | GCJ | Class II | |
| K911101 | Tonguetouch Keypad and Zofcom Control System | Zofcom, Inc. | IQA | Class II | |
| K910879 | Plastic (Vinyl) Examination Gloves | Siamount Plastic Corporation, Ltd. | LYZ | Class I | |
| K910779 | Disposable Electrosurgical Blade | Conmedcorp | GEI | Class II | |
| K910656 | Wilson-Cook Disposable Biopsy Forceps | Wilson-Cook Medical Inc. | FLC | Class II | |
| K910410 | Surgical Gowns, Extra-Large Size | Dawn of Hope Development Center | FYC | Class II | |
| K910214 | Ams 700 Ultrex(tm) Preconnected Penile Prosthesis | American Medical Corp. | FAE | Class II | |
| K905470 | Standard Rubber Dam with or without Frames | Elastomade Accessories Sdn Bhd | EIE | Class I | |
| K905173 | Splash Guard | E.M. Adams Co., Inc. | KYZ | Class I | |
| K905117 | Endoscope and Accessories | Northgate Technologies Inc. | GCI | Class II | |
| K905116 | Pharm-Assist | Excel Medical, Inc. | LHI | Class II | |
| K904955 | Consumer Sensory Products Bio-Log 8000 | Consumer Sensory Products, Inc. | FLL | Class II | |
| K904699 | Compac(tm) Diode Lasers | Hgm Medical Laser Systems, Inc. | HQF | Class II | |
| K911631 | Pharmacia Specific Ige Control | Pharmacia, Inc. | DGC | Class II | |
| K911527 | Novoste Guiding Catheter | Best Vascular, Inc. | DQY | Class II | |
| K910853 | Graduated Cylinder of External Drainage Set | Cordis US Corp. | JXG | Class II | |
| K910673 | Bag Spigot | Procedure Products, Inc. | KPE | Class II | |
| K910593 | Roche Reagent for Direct Bilirubin | Roche Diagnostic Systems, Inc. | CIG | Class II | |
| K910591 | Roche Reagent for Total Bilirubin | Roche Diagnostic Systems, Inc. | CIG | Class II | |
| K910437 | Fuji Computed Radiography System Fcr 7501 | FUJIFILM Healthcare Americas Corporation | LLZ | Class II | |
| K910319 | Acid Concentrate Solutions | Biopharm, Inc. | KPO | Class II | |
| K910204 | Swan-Ganz(r) Hi-Shore(r) Thermo Cath W/amc(tm) | Baxter Healthcare Corporation | DQO | Class II | |
| K904538 | Mauna Loa Enhanced Heated Breathing Circuit | Mauna Loa Medical, Inc. | CAI | Class I | |
| K911608 | Granstand | Prime Engineering | IPL | Class II | |
| K911484 | Laparoscopic Suction Irrigation Tubing Set | United States Endoscopy Group, Inc. | GCJ | Class II | |
| K911405 | Kodak Ektascan Digital Interface/for At&t | Eastman Kodak Company | LMD | Class I | |
| K910817 | Ge Quadrature Cervical Spine Surf Coil, M1285ar | General Electric Co. | LNH | Class II | |
| K905593 | Sleepap | Medical Industries America, Inc. | BZD | Class II | |
| K904599 | D2 Spectrum Gamma Camera/crystal V Computer System | Digital Design, Inc. | JWM | Class II |