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 |
|---|---|---|---|---|---|
| K903770 | Mrt 50A | Toshiba America Mri, Inc. | LNH | Class II | |
| K903768 | Magnetic Resonance Device Mrt 150A | Toshiba America Mri, Inc. | LNH | Class II | |
| K903518 | Abo-1122 Analog Ball Overdenture | Minimatic Implant Technology | DZE | Class II | |
| K903367 | Ketone Test a Sanwa Standard | Ihara Medics U.S., Inc. | JIN | Class I | |
| K903366 | Ketone Test B Sanwa Standard | Ihara Medics U.S., Inc. | JIN | Class I | |
| K903318 | Magnetic Resonance Diagnostic Device Mobile Mrp-30 | Summit World Trade Corp. | LNH | Class II | |
| K903086 | Tube Gastrostomy | Knight Medical, Inc. | KGC | Class II | |
| K903057 | Freevent (Tm) | Pharma Systems AB | BYD | Class I | |
| K903044 | Tc-1111 Transfer Pin | Minimatic Implant Technology | DZE | Class II | |
| K902930 | Device Part Number: Svd-3S Drill | Minimatic Implant Technology | DZE | Class II | |
| K902836 | Microetcher | Danville Engineering, Inc. | KOJ | Class II | |
| K902526 | Capd Disposable Disconnect Y-Set Code: 5C4481 | Baxter Healthcare Corporation | KDJ | Class II | |
| K902426 | Hemodialysis System and Accessory | Gainor Medical Europe, Ltd. | FJK | Class II | |
| K902421 | Stomach, Gastro-Enterostomy | Gainor Medical Europe, Ltd. | KDH | Class II | |
| K902410 | Medical Procedure Tray | Sorex Medical | LDQ | ||
| K901803 | Syringe Needle Introducer | Glaxo, Inc. | KZH | Class II | |
| K905033 | Slimflex, Patient Examination Gloves | Slim River Latex Sdn. Bhd. | LYY | Class I | |
| K904855 | Add-a-Vial | Kendall Mcgaw Laboratories, Inc. | LHI | Class II | |
| K904150 | Cath-Finder(tm) Catheter Tracking System | Pharmacia Deltec, Inc. | FOZ | Class II | |
| K904138 | Smart Scale X-Ray Platform | Olympic Medical Corp. | FRW | Class I | |
| K904096 | Photac-Bond | Espe GmbH (US) | EJK | Class II | |
| K903666 | Ophthasonic A/p III | Teknar, Inc. | HPY | Class I | |
| K903325 | Flexiflo (R) Versa-Peg (Tm) Gastrostomy Kit | Abbott Medical | KNT | Class II | |
| K903036 | P.r.g. Guidewire Placement System | Applied Medical Technologies | KGC | Class II | |
| K902813 | Shave Prep Tray | Orion Life Systems, Inc. | |||
| K902764 | Emerson 33-an Negative Pressure Respirator Alarm | J. H. Emerson Co. | BYT | Class II | |
| K902428 | Integrated Diagnostic System W/add'l Options | GE Healthcare | LLZ | Class II | |
| K901163 | Wilson-Cook Pull Through Peg Kit | Wilson-Cook Medical Inc. | FPD | Class II | |
| K904216 | Sterile Water Solution Catalog # 10000 | Superior Healthcare Group, Inc. | JOL | Class II | |
| K903930 | Datascope Percor Stat Dl 10.5 Fr 50Cc | Datascope Corp. | DSP | Class II | |
| K903839 | Interspec Apogee | Interspec, Inc. | DXK | Class II | |
| K903437 | Dispos Access External Cardiac Pacemaker | Keller Medical Specialties Products, Inc. | DRO | Class II | |
| K903337 | 1.9 French Lithotripter Electrode | Northgate Research, Inc. | FFK | Class II | |
| K902722 | Bard Laparoscopic Irrigator Pump System | Davol, Inc. | HET | Class II | |
| K901514 | Xr Model H Physiological Monitor & Recording Sys. | Ppg Industries, Inc. | DSK | Class II | |
| K900433 | Smooth Staple Implant | Interphase Implants, Inc. | MDL | Class II | |
| K896825 | Transcutaneous Electronic Nerve Stimulator | Infrasonics Corp. | GZJ | Class II | |
| K895137 | Diotherm | Science Regulatory Services Intl. | FLL | Class II | |
| K904517 | Mammospot 3 and Mammospot 8 | American Mammographics, Inc. | IZH | Class II | |
| K903651 | Ami Mammospot | American Mammographics, Inc. | IZH | Class II | |
| K903004 | Ee1114, 1118, 1121 Electro-Encephalograph | Teca, Inc. | GWQ | Class II | |
| K904891 | Nonabsorbable Silk Surgical Suture (Second Source) | United States Surgical, A Division of Tyco Healthc | GAP | Class II | |
| K904478 | Nonabsorbable Silk Surgical Suture | United States Surgical, A Division of Tyco Healthc | GAP | Class II | |
| K904590 | Kodak Ektascan Laser Printer, Model 100 Xlp | Eastman Kodak Company | LLZ | Class II | |
| K904555 | Durafill Flow | Kulzer GmbH | EBF | Class II | |
| K904474 | Haemonetics Ln 200F Collection Reservoir | Haemonetics Corporation | CAC | Class II | |
| K904463 | Accuprobe Mycobacterium Kansasii Cult Confirm Test | Hologic, Inc. | LQF | Class I | |
| K904397 | Tec 1410 | Bay Shore Medical Equipment, LLC | IZO | Class I | |
| K904363 | Multi Format Video Imager 600 Plus | International Imaging Electronics | LMC | Class II | |
| K904297 | St-4 Coagulation Instrument | American Bioproducts Co. | GKP | Class II |