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 |
|---|---|---|---|---|---|
| K012479 | Sterile Nitrile Surgical Gloves (Powdered) | Smart Glove Corp. Sdn Bhd | KGO | Class I | |
| K012397 | Urisys 2400 Urine Test Strip | Roche Diagnostics GmbH | JIL | Class II | |
| K012298 | The Intuitive Colorimeter | Cerium Optical Technologies, Inc. | NFD | Class I | |
| K012084 | Sonoreal 3D | Bio Medi Com | IYO | Class II | |
| K011970 | Biosafe Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | CHH | Class I | |
| K011961 | Powder-Free Butadiene Copolymer Exam Gloves with Aloe, Vitamins E Ph5.5 | Shen Wei (USA), Inc. | LZA | Class I | |
| K011877 | Ff450 Plus Fundus Camera and Visupac Digital Image Archiving System, or Ff450 Plus Visupac System | Carl Zeiss Jena GmbH | HKI | Class II | |
| K013099 | Modification to: Qwh-420 Wrist Array Coil | Mri Devices Corp. | MOS | Class II | |
| K012922 | Ultraflex Ev Hemostasis Introducer | Abbott Medical | DYB | Class II | |
| K012865 | Superstitch Vascular Suturing Device | Sutura, Inc. | GAW | Class II | |
| K012411 | Hp-One | Gi Supply | LYR | Class I | |
| K012106 | Accuimage Smartgate Upgrade | Accuimage Diagnostics Corp. | JAK | Class II | |
| K012074 | Xbo1-824-18/19/20 Biopsy Forceps | Olympus Optical Co., Ltd. | OCZ | Class II | |
| K012004 | Easy Guide Electrosurgical Access Device | Senorx, Inc. | GEI | Class II | |
| K010891 | Modification to Hybrid Capture II Ct/gc Test, Model 03M90-01 | Qiagen | LSK | Class I | |
| K012984 | Breathable Impervious Gowns | Medtronic, Inc. | FYA | Class II | |
| K012970 | Ge Signa Asset Imaging Option | GE Healthcare | LNH | Class II | |
| K012870 | Xia Stainless Steel System | Howmedica Osteonics Corp | KWP | Class II | |
| K012250 | Raichem Multi-Analyte Calibrator | Hemagen Diagnostics, Inc. | JIX | Class II | |
| K012190 | Aos Modular Femoral Nail | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | |
| K012149 | Powder-Free Latex Examination Gloves with Protein, Chemotherapy Labeling Claim | Medtronic, Inc. | LYY | Class I | |
| K012043 | Vacuette Edta K2 Gel Tubes | Greiner Bio-One North America, Inc. | PJE | Class II | |
| K012030 | Portable Intensive Care Unit | Medical Research Laboratories, Inc. | MKJ | Class III | |
| K011017 | Promax-Xp, TENS and Microcurrent Device; Promax-TENS, TENS Device; Promax-Libra, TENS Device; Promax-Mc, Microcurrent | Rehabilicare, Inc. | GZJ | Class II | |
| K010893 | Modification to Hybrid Capture 2 Gc-Id DNA Test, Model 03M92-01 | Qiagen | LSL | Class II | |
| K010892 | Modification Hybrid Capture II CT-Id DNA Test, Model 03M91-01 | Qiagen | LSK | Class I | |
| K012904 | Advia 120 Hematology System, Cyanide-Free High Determination | Bayer Diagnostics Corp. | GKZ | Class II | |
| K012863 | Non-Sterile Powder Free Latex Examination Gloves with Vanilla and Protein Content Labeling Claim (50 Micrograms or Less) | Sgmp Co., Ltd. | LYY | Class I | |
| K012860 | Powder-Free Latex Exam Gloves with Chocolate Scenting and Protein Labeling Claim (<50Ug/g) | Sgmp Co., Ltd. | LYY | Class I | |
| K012857 | Non-Sterile Powder Free Purple Latex Examination Glove with Blueberry Scented and Protein Content Claim (50 Micrograms O | Sgmp Co., Ltd. | LYY | Class I | |
| K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc | JXI | Class II | |
| K012653 | Male Latex Condom | Qingdao Shuang die Latex Production Co.,Ltd | HIS | Class II | |
| K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | ERL | Class II | |
| K012352 | Sqa, Sperm Quality Analyzer | Medical Electronic Systems Ltd. | POV | Class II | |
| K012329 | Wiener Lab.albumina Aa, Models 6X60 Ml Cat N 1690008, 6X120 Ml Cat 1009300 | Wiener Laboratories Saic | CIX | Class II | |
| K012306 | Audioscan Verifit, Model Vf-1 | Etymonic Design, Inc. | ETW | Class II | |
| K012093 | Aetmed Image Processing Software | Aetmed, S.p.A. | LLZ | Class II | |
| K012008 | Sts Range , Models Sts20,sts30,sts40 | Huntleigh Healthcare Ltd. | JOW | Class II | |
| K011343 | Lh 500 Enteral Feeding Gravity Bag Set | Lh Medical Products, Inc. | KNT | Class II | |
| K011341 | Lh400 Yes-Set Y-Port Enteral Spike Pump Set | Lh Medical Products, Inc. | KNT | Class II | |
| K011340 | Lh 450 Enteral Feeding Bag Pump Set W/integrated Y-Port | Lh Medical Products, Inc. | KNT | Class II | |
| K010844 | Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part No. 80-8000-13K | Astoria-Pacific, Inc. | NAK | Class II | |
| K010232 | Pre-Powdered Nitrile Examination Gloves | P.T. Healthcare Glovindo | LZA | Class I | |
| K004023 | Intra Operative Radiation Therapy | Arplay Medical S.A. | IYE | Class II | |
| K991250 | Quantum Versatility Implant System | Quantum Bioengineering, Ltd. | DZE | Class II | |
| K013018 | Reaads Anti-Phosphatidylserine Iga Semi-Quantitive Test Kit | Corgenix, Inc. | MID | Class II | |
| K012150 | Patton Endo-Bag | Patton Medical Corp. | GCJ | Class II | |
| K012098 | Preclude Pericardial Membrane | W. L. Gore & Associates, Inc. | DXZ | Class II | |
| K012082 | Optibond Solo Plus Activator | Sybron Dental Specialties, Inc. | KLE | Class II | |
| K012042 | Kinetic Cannula | Reliance Medical Corp. | QPB | Class II |