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 |
|---|---|---|---|---|---|
| K943007 | Itp-Hvpc Galvanic Stimulator | Innovative Therapy Products, Inc. | IPF | Class II | |
| K954639 | Sunglasses | Walmart Stores | HQY | Class I | |
| K954636 | Blinde Optics | Blinde Eyewear, Inc. | HQY | Class I | |
| K954393 | Sinclair Non-Prescription Sunglasses | Sinclair Corp. | HQY | Class I | |
| K954213 | Ath Full Profile Acetabular Cup System | Kinamed Inc | LPH | Class II | |
| K954000 | Roche Reagent for Bun | Roche Diagnostic Systems, Inc. | CDQ | Class II | |
| K953808 | Cheng Chen Hsing Non-Prescription Sunglasses | Cheng Chen Hsing Enterp. & Fact. Co., Ltd. | HQY | Class I | |
| K953744 | Amita Corporation Various Models of Sunglasses | Amita Corp. | HQY | Class I | |
| K953710 | Elx808 Automated Microplate Readers | Bio-Tek Instruments, Inc. | JJQ | Class I | |
| K953702 | Washer | Linvatec Corporation | MBI | Class II | |
| K953627 | New Sun Optical Non Prescription Sunglasses | New Sun Optical Enterprise Co., Ltd. | HQY | Class I | |
| K953570 | Philips Multi Leaf Prescription Entry System (Mlp) | Philips North America LLC | IYE | Class II | |
| K953482 | Xknife-3 | Radionics Software Applications, Inc. | IYE | Class II | |
| K951757 | Driving Glasses | Proview Optical Group Corp. | HQY | Class I | |
| K950709 | Synergy Ti Anterior Spinal System | Cross Medical Products, Inc. | KWQ | Class II | |
| K950656 | Ped Alert | Orbitec Technologies Corp. | IRN | Class II | |
| K945838 | Ctport CT Simulation System for Radiotherapy | Toshiba America Medical Systems, In.C | KPQ | Class II | |
| K945642 | Agen Dimertest Gold Eia | Agen Biomedical, Ltd. | GHH | Class II | |
| K954521 | Mammospot Paddle | American Mammographics, Inc. | IZH | Class II | |
| K954196 | Universix 120 | Philips North America LLC | KPR | Class II | |
| K954055 | Hdx Digital Imaging System | Imacom, Inc. | LLZ | Class II | |
| K954021 | External Drainage System (Eds and Eds II) | Johnson & Johnson Professionals, Inc. | JXG | Class II | |
| K953802 | Tympanostomy Tube | Bluff City Medical Technologies, Inc. | ETD | Class II | |
| K953584 | Lifeshield Luer Activated Valve Male Adapter Plug | Abbott Medical | FPA | Class II | |
| K953552 | Sienet Spi Spooler | Siemens Medical Solutions USA, Inc. | LMD | Class I | |
| K953503 | Pressureguard IV | Span-America Medical Systems, Inc. | FNM | Class II | |
| K953483 | Sims Blue Line Endobronchial Tube | Smiths Industries Medical Systems, Inc. | CBI | Class II | |
| K953430 | Ultrasound Probe Biopsy Accessories | Biosound, Inc. | ITX | Class II | |
| K953412 | Candela Model Pltl-1 Laser System | Candela Corporation | GEX | Class II | |
| K953400 | Guedel Airway | Mallinckrodt Medical | CAE | Class I | |
| K953255 | Nuquest Nuclear Medicine Computer | Sitco, Inc. | KPS | Class II | |
| K953193 | Scintron IV | Medical Imaging Electronics America, Inc. | KPS | Class II | |
| K952895 | Cms Urethral Warmer | Cryomedical Sciences, Inc. | GEH | Class II | |
| K951977 | Digital Blood Pressure Meter - Model No.: Bpm883 | Integrated Display Technology, Ltd. | DXN | Class II | |
| K951919 | B-D Pen Ultra | BD Becton Dickinson Vacutainer Systems Preanalytic | FMF | Class II | |
| K950004 | Heartview(tm) 12-Lead Electrocardiograph Recorder/transmitter | Aerotel Ltd. | DPS | Class II | |
| K945855 | A-Fact, Abnormal Factor Assay Control | George King Bio-Medical, Inc. | GGN | Class II | |
| K945854 | B-Fact, Borderline Factor Assay Control | George King Bio-Medical, Inc. | GGN | Class II | |
| K941599 | Mitek Absorbable Anchor | Mitek Surgical Products, Inc. | MNV | Class II | |
| K954693 | Mehta Bronchial Biospy Drill | United States Endoscopy Group, Inc. | FCK | Class II | |
| K954633 | Conmed Electrosurgical Grounding Pad | Conmedcorp | GEI | Class II | |
| K954621 | Reclosable Wound Cover | Hollister, Inc. | FRO | Unclassified | |
| K954476 | Probe | Phx Technologies Corp. | HRX | Class II | |
| K954475 | Blunt Dissector, Curved | Phx Technologies Corp. | HRX | Class II | |
| K954464 | Carpal Tunnel Slotted Cannula | Phx Technologies Corp. | HRX | Class II | |
| K954463 | Dissecting Obturator | Phx Technologies Corp. | HRX | Class II | |
| K954459 | Conical Obturator | Phx Technologies Corp. | HRX | Class II | |
| K954458 | Boat Nose Obturator | Phx Technologies Corp. | HRX | Class II | |
| K954435 | Wilomat Sterilizable Clip Forceps W/interchangable Magazines | Wilo Medizintechnik Lothar Wilberg GmbH | FZP | Class II | |
| K954414 | Centralite Backpointer | Diacor, Inc. | IWE | Class I |