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 |
|---|---|---|---|---|---|
| K991394 | Stapes Prostheses | Grace Medical, Inc. | ETB | Class II | |
| K991324 | Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male) | Heinz Kurz | KHJ | Class II | |
| K990964 | Signadress Duoderm Dressing | Convatec, A Division of E.R. Squibb & Sons | KGN | Unclassified | |
| K990955 | Modification Of:bioderm Foam Wound Dressing | Bioderm, Inc. | KMF | Class I | |
| K990936 | The Vault | Stik Stoppers, Inc. | FMI | Class II | |
| K990672 | Lacrimal Intubation Set, Dacryocystorhinostomy (Dcr) Set | Hurricane Medical | OKS | Unclassified | |
| K990509 | Oligon Foley Catheter (16 Fr) #33816/Oligon Foley Catheter (18 Fr) #33818 | Implemed, Inc. | EZL | Class II | |
| K990493 | Innerdyne Generic Radially Expanding Dilation, G-Red Device | Innerdyne, Inc. | GCJ | Class II | |
| K984022 | Pediatric Two-Lumen Hemodialysis Catherization Kit | Arrow Intl., Inc. | MPB | Class II | |
| K982925 | Laminoss Dental Implant | Impladent, Ltd. | DZE | Class II | |
| K991627 | Wallaby 3 Phototherapy System, Model 3600 | Respironics, Inc. | LBI | Class II | |
| K991461 | Osteonics Scorpio Total Knee Relaxed Back P/s Tibial Bearing Insert | Howmedica Osteonics Corp | JWH | Class II | |
| K991172 | Ionosit Bond | DMG Chemisch Pharmazeutische Fabrik GmbH | EMA | Class II | |
| K991030 | Proximate Hcs Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K990935 | Jackson Esophageal Dilator | Pilling Weck Surgical | KNQ | Class II | |
| K990879 | Pre Powdered Latex Examination Gloves | Apl Products Sdn. Bhd. | LYY | Class I | |
| K990848 | Transfx Intermediate External Fixation System,transfx Small External Fixation System, Transfx Mini External Fixation | Immedica, Inc. | LXT | Class II | |
| K990841 | Nugard Nitril Nitrile Examination Glove | Terang Nusa (Malaysia) Sdn. Bhd. | LZA | Class I | |
| K990840 | Nugard Nitril Powderfree Nitrile Examination Glove | Terang Nusa (Malaysia) Sdn. Bhd. | LZA | Class I | |
| K990716 | Gallini Bycut Needle | Gallini U.S., LLC | KNW | Class II | |
| K990699 | Ortho-Glow Glitter | Harry J. Bosworth Co. | EBI | Class II | |
| K990669 | Multiple-Brand Male Latex Condom (Lubricated with Nonoxynol-9) | Dongkuk Techco Rubber Industries Sdn. Bhd. | LTZ | Class II | |
| K990665 | Bq/bm Integrated Laser Delivery System | American Laser Corp. | HQF | Class II | |
| K990652 | Interacoustics Model Az26 Clinical Impedance Audiometer | Idem (Int'L Dist. of Electronics for Medicine) | ETY | Class II | |
| K990586 | Conmed Abc Probe for Flexible Endoscopes | Conmedcorp | GEI | Class II | |
| K990585 | Interacoustics At22t Automatic Impedance Audiometer | Idem (Int'L Dist. of Electronics for Medicine) | ETY | Class II | |
| K990474 | Oratec Interventions Ora-50 S Programmable Electrothermal Spine System and Accessories | Oratec Interventions, Inc. | GEI | Class II | |
| K990381 | Totalbond | Parkell, Inc. | EMA | Class II | |
| K984229 | Latex Examination Gloves (Powdered) | Sama Kejuruteraan Sdn.Bhd. | LYY | Class I | |
| K984052 | Synergy Iom System | Oxford Instruments Medical Systems | IKN | Class II | |
| K983720 | Asahi Am-Bio Series Dialyzers (Wet Models)& (Dry Models), Models Am-Bio-50,Am-Bio-65, Am-Bio-75, and Am-Bio-100, Am-Bio- | Asahi Kasei Medical MT Corp. Oita Works | MSE | Class II | |
| K983665 | Manometric Assemblies | Dentsleeve Pty., Ltd. | KLA | Class II | |
| K983216 | Cvs Personal Lubricant | San-Mar Laboratories, Inc. | HIS | Class II | |
| K991550 | Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical Handling Tint and Colored Soft (Hydrophilic0 Contact Lens | Wesley Jessen Corp. | LPL | Class II | |
| K991459 | Copalis Ebv-M Antibody Assay | Diasorin Inc. | LJN | Class I | |
| K991404 | Platypus Av Fistula Needle Protector (Avfnp) | Itl Corporation Pty, Ltd. | FMI | Class II | |
| K991298 | Bone Mulch Screw System | Zimmer GmbH | HWC | Class II | |
| K991224 | K-Assay Crp | Kamiya Biomedical Company, LLC | DCK | Class II | |
| K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 | Pharmacia & Upjohn Company LLC | DHB | Class II | |
| K990693 | Flexneedle Plus | Act Medical, Inc. | FPA | Class II | |
| K990650 | Conseal F | Southern Dental Industries, Inc. | EBC | Class II | |
| K990620 | Excelart | Toshiba America Mri, Inc. | LNH | Class II | |
| K990568 | Scrambled Endooto Laser Probe, Straight Tip, Model 59.02, Scrambled Endooto Laser Probe Bent Tip, Model 59.01 | Synergetics Inc | GEX | Class II | |
| K990566 | Tas Analyzer, Model 1009 | Cardiovascular Diagnostics, Inc. | JPA | Class II | |
| K990561 | Optical Forceps | Pilling Weck Surgical | JEK | Class II | |
| K984537 | Keratome System, Model K3000 | Insight Technologies Instruments, LLC | HMY | Class I | |
| K983875 | Vitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products Ca 125 II Reagent Pack | Ortho-Clinical Diagnostics, Inc. | LTK | Class II | |
| K983715 | The Immuno 1 Ca 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System) | Bayer Corp. | LTK | Class II | |
| K991501 | Acclaim Infusion Pump | Abbott Medical | FRN | Class II | |
| K991484 | Airlife Bubble Humidifer, Model 002003 and 002006 | Medtronic, Inc. | BTT | Class II |