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 |
|---|---|---|---|---|---|
| K962678 | Bipolar Pencil Coagulator | Kirwan Surgical Products, LLC | GEI | Class II | |
| K962670 | Nhmc Irrigation Tray | National Healthcare Mfg. Corp. | LJH | Class II | |
| K962463 | Procainamide Enzyme Immunoassay | Diagnostic Reagents, Inc. | LAR | Class II | |
| K962461 | Nitrile Powder-Free Patient Examination Gloves | Shen Wei (USA), Inc. | LZA | Class I | |
| K962287 | Eagle Eyes Sunglasses | Positive Response Television | HQY | Class I | |
| K962162 | Dall-Miles Trochanter Cable Supergrip | Howmedica Corp. | JDQ | Class II | |
| K962152 | Osteonics Scorpio Posteriorly Stabilized Total Knee System | Osteonics Corp. | JWH | Class II | |
| K962048 | 1W/kg Sar(part of Version 6-05 Operating System Software) | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K961914 | Bacteria/viral Filter | Hudson Respiratory Care, Inc. | CAH | Class II | |
| K961894 | Mdi Tutor | Mdi Tutor, Inc. | CCQ | Class I | |
| K961893 | Duraflor | Pharmascience, Inc. | LBH | Class II | |
| K960871 | Spectrolyse Antithrombin III (Anti-Xa) | Medical Diagnostic Technologies, Inc. | JBQ | Class II | |
| K960656 | Gore Burr Hole Cover | W. L. Gore & Associates, Inc. | GXR | Class II | |
| K960474 | Cobe Centrysystem 600 Hg Hemodialyzers | Cobe Renal Care, Inc. | KDI | Class II | |
| K955931 | Model Im77 Intrapartum Fetal Monitor (Modification) | Advanced Medical Systems, Inc. | HGM | Class II | |
| K955719 | Sickle-2000 | Medicus Technologies, Inc. | GIQ | Class II | |
| K962476 | Unscented Menstrual Tampon, Plastic Applicator | Tambrands Inc. | HEB | Class II | |
| K962082 | Osteonics All Polyethylene Glenoid Shoulder Component | Osteonics Corp. | KWS | Class II | |
| K961983 | Trs 2000 Teleradiology System | Sectra-Imtec AB | LLZ | Class II | |
| K961939 | S-Rom Femoral Hip Stem(sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | LPH | Class II | |
| K961927 | Rmi Hemoconcentractor Tubing Set | Research Medical, Inc. | DWF | Class II | |
| K961867 | PEEP Valve | Medical Marketing Concepts | BYE | Class II | |
| K961814 | Thrombolytic Assessment System Prothrombin Time Test Controls | Cardiovascular Diagnostics, Inc. | GIZ | Class II | |
| K954205 | The Amplatz Thrombectomy Device | Microvena Corp. | MCW | Class II | |
| K953946 | Microselectron-Hdr Version 2 | Nucletron-Oldelft Corp. | JAQ | Class II | |
| K952614 | Jeltrate Plus Antimicrobial Impr. Material | Dentsply Intl. | ELW | Class II | |
| K962785 | 3M Dent System | 3M Company | KLE | Class II | |
| K962005 | Extrahand Balloon Retractor | Origin Medsystems, Inc. | GCJ | Class II | |
| K961869 | Dideco Newborn/infant Arterial Filters: D735 Micro 20 and D736 Micro 40 | Sorin Biomedical, Inc. | DTM | Class II | |
| K960843 | Stop-N-Grow | European Touch Co., Inc. | MQZ | Unclassified | |
| K960749 | Hemochron Jr. Microcoagulation Low Range Act | Accriva Diagnostics, Inc. | JBP | Class II | |
| K960686 | Hycoat | The Hymed Group Corp. | MGQ | Unclassified | |
| K960445 | Input Tuohy-Borst Locking Device | C.R. Bard Inc | DYB | Class II | |
| K955742 | D. Device II | Yousef Daneshvar | DXC | Class II | |
| K954789 | Brainlab Headpins | Brainlab, Inc. | HAW | Class II | |
| K952163 | David Back Clinic System | Kinetic Resources, Inc. | ISD | Class II | |
| K952050 | Glove, Examination, Vinyl | Oak Carolina, Inc. | LYZ | Class I | |
| K962847 | Mt10p, Mt60-Pp, Mt60-Agc0, and Mt60 | Micro-Tech Hearing Instruments | ESD | Class I | |
| K962693 | Montgomery Radiopaque Laryngeal Keel | Boston Medical Products, Inc. | FWN | Class II | |
| K962600 | Rexam Self-Seal Tyvek Pouch | Rexam Medical Packaging, Inc. | KCT | Class II | |
| K962533 | Olypus Fg Series Grasping Forceps | OLYMPUS Corporation of the Americas | EOQ | Class II | |
| K962530 | Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh | Ethicon, Inc | FTL | Class II | |
| K962380 | Olympus Bf Type 200 Video Bronchscopes(bf-200/Bf-P200/bf-It200) | OLYMPUS Corporation of the Americas | EOQ | Class II | |
| K962328 | Single Use Instrument Tray | Medcare Medical Group, Inc. | FSM | Class I | |
| K962244 | Select Shoulder Pegged All-Poly Glenoid | Intermedics Orthopedics | KWT | Class II | |
| K962238 | Select Shoulder Keeled All-Poly Glenoids | Intermedics Orthopedics | KWT | Class II | |
| K962119 | Re-New Laparoscopic Instruments | Microline Pentax, Inc. | GEI | Class II | |
| K961922 | Rdp-2 | Ranfac Corp. | HET | Class II | |
| K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | KPI | Class II | |
| K961855 | Polar Care (Model 500/50000) | Breg, Inc. | ILO | Class II |