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 |
|---|---|---|---|---|---|
| K011867 | Liquid Assayed Multiqual Control Level1 #981600; Level 2 #981700; Level 3 #981800 | Bio-Rad | JJY | Class I | |
| K011862 | Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt | Denver Biomedical, Inc. | KPM | Class II | |
| K011786 | Vacuette Safety Blood Collection Set | Greiner Bio-One North America, Inc. | FMI | Class II | |
| K011606 | Puresperm Buffer | Nidacon International AB | MQL | Class II | |
| K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | EBI | Class II | |
| K011557 | Pta, Ptv, Atrioseptostomy, Angiographic, Sizing Catheters | Numed Inc | DXF | Class II | |
| K011395 | Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B | Medtronic, Inc. | KRH | Class II | |
| K011291 | Temporalscanner Thermometer, Sensortouch | Exergen Corporation | FLL | Class II | |
| K011155 | Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S | Ibt SA | KXK | Class II | |
| K003954 | Stimulan - Calcium Sulfate Bone Void Filler Kit | Biocomposites, Ltd. | MQV | Class II | |
| K003779 | Immobilization System for ENT | Arplay Medical S.A. | IYE | Class II | |
| K003045 | Ha-Ti (Hand Titanium Screw) Implant | Hati Dental AG. | DZE | Class II | |
| K000266 | Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation | Primary Care Solutions, Inc. | JOL | Class II | |
| K000265 | Primary Care Solutions Sterile Water Device Irrigation | Primary Care Solutions, Inc. | JOL | Class II | |
| K011987 | Modified M-IV Mammography System | Hologic, Inc. | IZH | Class II | |
| K011851 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K011825 | Rectosight Rs300-04;And Protosight Ps300-04 Device | Sightline Technologies, Ltd. | FER | Class II | |
| K011229 | Devilbiss 9000 Series CPAP, Model 9001 | Sunrise Medical Hhg, Inc. | BZD | Class II | |
| K011173 | Telepax | Imed Systems & Consulting, LLC | LLZ | Class II | |
| K011129 | Sign Im Nail | Sign, Inc. | HSB | Class II | |
| K003823 | Scs Dt-02 Transverse Connector | Ortho Tec, LLC | KWP | Class II | |
| K003551 | Venous Hardshell Cardiotomy Resevoir, Model Vhk 4201 | Jostra AG | DTN | Class II | |
| K002207 | Macroporepx Pediatric System | Macropore Biosurgery, Inc. | JEY | Class II | |
| K011997 | Modular Valve Handles for Adaptable Tubes, Model 1298-Xx-Xx, 1295-Xx-Xx | Pajunk GmbH Medizintechnologie | GCJ | Class II | |
| K011924 | Powdered Blue Nitrile Examination Gloves | Seltom Pacific Sdn. Bhd. | LZA | Class I | |
| K011882 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | |
| K011834 | Bis Engine | Aspect Medical Systems, Inc. | OLW | Class II | |
| K011808 | Asia-Med Acupuncture Needles, (Standard, Special, Compact, Apex) | Asia-Med GmbH and CO KG | MQX | Class II | |
| K011517 | Lute; Core | First Scientific Limited | EBF | Class II | |
| K011497 | Cymun-Nbr Powder Free Blue Nitrile Examination Glove | Tillotson Healthcare Corp. | LZA | Class I | |
| K011422 | Surgical Drapes | Advance Medical Designs Inc | KKX | Class II | |
| K011311 | Urologic | Pck Electronic Industry & Trade Co., Ltd. | OWB | Class II | |
| K011293 | Powder Free Polymer Coated Latex Medical Examination Gloves, Non-Sterile W/ Protein Content Labeling Claim 50 Mcg or Les | Multisafe Sdn Bhd | LYY | Class I | |
| K011254 | Ear Thermometer, Models St613c and St613f | Mesure Technology Co., Ltd. | FLL | Class II | |
| K011205 | Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125 | Isoaid, L.L.C. | KXK | Class II | |
| K011138 | Oxford Unicompartmental Knee Femoral Component | Zimmer GmbH | HRY | Class II | |
| K010748 | Synchron Systems Hemoglobin A1c Reagent | Siemens Healthcare Diagnostics Inc. | LCP | Class II | |
| K010546 | Powder Free Latex Examination Gloves | Jb Star Sdn Bhd | LYY | Class I | |
| K011895 | Powder-Free Multi-Ply Latex Examination Gloves, Polymer Coated on Outside and Nitrile Coated on Inside, Blue Color with | Pwa Industries Sdn. Bhd. | LYY | Class I | |
| K011864 | Trillium Myotherm Xp Cardioplegia Delivery System, Models 41, 41-B | Medtronic, Inc. | DTN | Class II | |
| K011804 | Capiox Arterial Filter with X-Coating, Product Code Cx*afo2x | Terumo Cardiovascular Systems Corporation | DTM | Class II | |
| K011728 | Brightway Brand Powder Free Latex Examination Gloves, Blue Non-Sterile, Protein Labeling Claim (50 Micrograms or Less) ( | Brightway Holdings Sdn. Bhd. | LYY | Class I | |
| K011669 | Bw Acupuncture Needles | H F Intl. Co. | MQX | Class II | |
| K011668 | Validation of the Breathid System, for the Detection of Helicbactor Pylori | Oridion Medical 1987 Ltd. | MSQ | Class I | |
| K011570 | Quanta Lite H-Ttg (Human Tissue Transglutaminase) Igg Elisa | Inova Diagnostics, Inc. | MVM | Class II | |
| K011566 | Quanta Lite H-Ttg (Human Tissue Transglutaminase) Iga Elisa | Inova Diagnostics, Inc. | MVM | Class II | |
| K011512 | Mmodification to Laminaria | A & A Medical, Inc. | HDY | Class II | |
| K011498 | Easy Control Micro Inserter, Model On385 | Ophtec USA, Inc. | NCE | Class I | |
| K011482 | Dermasafe Chemo Plus Powder Free Neoprene Examination Glove (Tested for Use with Chemotherapy Drugs) | WRP Asia Pacific Sdn Bhd | LZA | Class I | |
| K011441 | Jas Calcium (Arsenazo) Reagent | JAS Diagnostics/Drew Scientific | CJY | Class II |