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 |
|---|---|---|---|---|---|
| K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | ArthroCare Corporation | FAS | Class II | |
| K960834 | Kodak Ec-L Cassette | Eastman Kodak Company | IYE | Class II | |
| K955241 | High Risk Gloves | Pan-Century Rubber Products Sdn. Bhd. | LYY | Class I | |
| K954884 | Pediatric Multiplane Transesophageal Probe (Pmpte-Probe), Tn100065 | Vingmed Sound, Inc. | IYO | Class II | |
| K952475 | Sullivan Nose & Mouth Mask System | Rescare, Ltd. | BZD | Class II | |
| K945936 | Jazzy | Pride Health Care, Inc. | ITI | Class II | |
| K945559 | Mar Cor Complete Water Treatment System for Kdney Dialysis | Mar Cor Services, Inc. | FIP | Class II | |
| K932889 | Perry Specialties Designs Needle Guard | Perry Specialties Design, Inc. | FMI | Class II | |
| K961584 | Fuji II Lc (Improved) | GC America Inc. | EMA | Class II | |
| K961417 | Gc Fuji Ortho | GC America Inc. | DYH | Class II | |
| K961370 | La Positive Control Plasma | Medical Diagnostic Technologies, Inc. | GGC | Class II | |
| K961198 | Bosworth Ch I | Harry J. Bosworth Co. | EBG | Class II | |
| K960945 | Imz Membrane Tack System | Interpore Intl. | DZL | Class II | |
| K960894 | Cd-Chex + Rbc | Streck Laboratories, Inc. | GGL | Class II | |
| K960467 | Powder Free Latex Examination Glove | Biopro, Inc. | LYY | Class I | |
| K960049 | Brannon Portsyringe | James K. Brannon | FMF | Class II | |
| K960047 | Brannon Pedi Portsyringe | James K. Brannon | FMF | Class II | |
| K960022 | Opti-Max Body Diameter W/5mm Top W/external Hex, Externally Threaded Dental Implant Coarse Threads | Opti-Max | DZE | Class II | |
| K955904 | Ektachem Dt Ldl Cholesterol Kit | Johnson & Johnson Clinical Diagnostics, Inc. | MRR | Class I | |
| K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | IYO | Class II | |
| K955633 | Enthanol (Rate) Assay, Catalogue No. 219-03 | Sekisui Diagnostics P.E.I. Inc. | DIC | Class II | |
| K955236 | Green Tec-2100 | Medtec LLC | IWE | Class I | |
| K954826 | Disetronic Multifuse Pump System | Disetronic Medical Systems | FRN | Class II | |
| K954258 | Trimport Implantable Access System (Modification) | Gerard Medical Enterprises, Inc. | LJT | Class II | |
| K946349 | Stenodoc | Specs USA, Inc. | IYO | Class II | |
| K961216 | Manan Introducer Shealth/needle | Argon Medical Devices, Inc | FGE | Class II | |
| K961158 | Suprasson P5 Booster | Satelec | ELC | Class II | |
| K961114 | Ast Incorporating Dst | Trace Scientific, Ltd. | CIT | Class II | |
| K960931 | Carolina Narrow Fabric Company Open Toe Anti-Embolism Stocking | Carolina Narrow Fabric Co. | DWL | Class II | |
| K960777 | Mdt Unispore and Spor-Test Biologicalindicator | Mdt Corp., Inc. | FRC | Class II | |
| K960755 | Cardiotherm Blood Cardioplegia Systems | Medtronic Cardiac Surgery, Medtronic, Inc. | DQX | Class II | |
| K960532 | Preclude Ima Sleeve | W. L. Gore & Associates, Inc. | MFX | Class II | |
| K960243 | CPR C-Section Delivery Pack | Custom Pack Reliability | MLS | Class II | |
| K960239 | CPR D & C Tray | Custom Pack Reliability | HHK | Class II | |
| K955561 | Buhlmann Vitamin B6 Rea | American Laboratory Products Company | CDD | Class II | |
| K955449 | Orgentec Anti-Cardiolipin Elisa Assay | American Laboratory Products Company | MID | Class II | |
| K955180 | Cadd-Pca, -Micro, -Prizm Ambulatory Infusion Pump | Sims Deltec, Inc. | FRN | Class II | |
| K953839 | Premier Hsv Plus | Meridian Diagnostics, Inc. | LGC | Class II | |
| K953205 | Constant Current Peripheral Nerve Stimulator Ns272 (Modification) | Fisher & Paykel Healthcare, Inc. | KOI | Class II | |
| K952802 | Visuwell Reagin II | Biomira Diagnostics, Inc. | GMQ | Class II | |
| K952273 | Handmaster Nms1 | Neuromusclar Electrical Stimulation Systems, Ltd. | IPF | Class II | |
| K950169 | Ribosomal P Eia Test System | Hogan & Hartson | MQA | Class II | |
| K961283 | Dall-Miles Homogenous Vitallium Cable | Howmedica Corp. | JDQ | Class II | |
| K961132 | Somnus Medical Tech Soft Tissue Coagulating Electrode | Somnus Medical Technologies, Inc. | GEI | Class II | |
| K961081 | Spirit Ridge Silicone Carving Block | Rand Scientific Corp. | MIB | Class II | |
| K961079 | Laser Peripherals Inc. Scatterfree Fiber | Laser Peripherals LLC | GEX | Class II | |
| K960955 | Jackson-Pratt Gold Wound Drains with Duraflo II Coating | Baxter Healthcare Corporation | GBX | Class I | |
| K960795 | Vygon Double Lumen Endotracheal Tube | Vygon Corp. | BTR | Class II | |
| K960774 | Micro21 with Ana | Triangle Biomedical Sciences, Inc. | JOY | Class II | |
| K960747 | Nature's Cradle Model C1500 | Infant Advantage, Inc. | FMS | Class II |