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 |
|---|---|---|---|---|---|
| K002400 | Modification of Acl Advance | Instrumentation Laboratory Co. | JPA | Class II | |
| K002319 | Purilens Saline Solution | Purilens, Inc. | LPN | Class II | |
| K002313 | Complexed Psa Microtiter Elisa | Oncogene Science, Inc. | LTJ | Class II | |
| K002312 | Proton Vision 7.0 | Varian Medical Systems, Inc. | MUJ | Class II | |
| K002195 | Foramatron V, Model D680 | Parkell, Inc. | LQY | Unclassified | |
| K002121 | Total Psa Microtiter Elisa | Oncogene Science, Inc. | LTJ | Class II | |
| K002048 | Jbc Opaque and Glitter | J.B.C and Co. | EBI | Class II | |
| K001946 | Neurovascular Array Coil | GE Healthcare | MOS | Class II | |
| K001818 | Uterine Tenaclum Hook | Towne Brothers (Pvt.), Ltd. | HDC | Class II | |
| K001420 | Slidescan | Applied Imaging Corp. | JOY | Class II | |
| K001338 | Microvasive Rapid Exchange Biliary Balloon Dilatation Catheter | Boston Scientific Corporation | FGE | Class II | |
| K001300 | D. R. Medical Controlled Pressure Garments | Confection Medicale D.R., Inc. | DWL | Class II | |
| K001127 | Anca Combi Diagnostic Kit with If-Aim Technology | The Binding Site | MOB | Class II | |
| K001052 | Med-Tec (Medical Intelligence) Bodyfix System, Model Mt-Bfx | Medtec LLC | IYE | Class II | |
| K000251 | Spectrum Silicone Foley Catheter | Cook Incorporated | MJC | Class II | |
| K002464 | Smith & Nephew Off-Centered Porp | Gyrus Ent LLC | ETB | Class II | |
| K002401 | Cidex Opa Solution (0.55% Orthro-Phthalaldehyde Solution) | Advanced Sterilization Products | MED | Class II | |
| K002378 | Modular Porp and Torp Model Tbd | Gyrus Ent LLC | ETA | Class II | |
| K002276 | Psi Skull Clamp | V. Mueller Neuro/Spine | HBL | Class II | |
| K002138 | Paradigm Silhouette, Models Mmt-377, 378, 379, 380 | Maersk Medical A/S | FPA | Class II | |
| K001938 | Vector Targeting System | Vector Medical, Inc. | HSB | Class II | |
| K001922 | Depuy Neuflex Pip Finger | Depuy, Inc. | KYJ | Class II | |
| K001903 | Neocontrol Pelvic Floor Therapy System | Neotonus, Inc. | KPI | Class II | |
| K001731 | Avid-Nit Loss of Resistance Syringe | Avid Medical, Inc. a Medical Action Ind. Company 305 | FMF | Class II | |
| K991495 | Fluid Process Systems Exchange Carbon and Deionization Tanks for Use in Hemodialysis | Fluid Process Systems, Inc. | FIP | Class II | |
| K001960 | Rigid Gas Permeable Contact Lens | Polymer Technology Corp. | HQD | Class II | |
| K001899 | Improved Try-in Gel | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K001648 | Intrastent Doublestrut Paramount | Intratherapeutics, Inc. | FGE | Class II | |
| K002351 | Fluorotex II Surgical Mesh | Bridger Biomed, Inc. | FTL | Class II | |
| K000983 | Ceramix Porcelain System | C-Mix | EIH | Class II | |
| K994198 | Hemofeel-Ch, Models Ch-0.35L, Ch-0.6L, Ch-1.0L | Toray Industries (America), Inc. | KDI | Class II | |
| K992831 | Aeroneb II, Model Apn 200 | Aerogen Ltd. | CAF | Class II | |
| K002491 | Combison 301 Pw Ultrasound System and Transducers | Medison Co., Ltd. | IYN | Class II | |
| K002388 | Ehc500 Desktop Patient Station, Model Ehc500 | Cybercare, Inc. | DXN | Class II | |
| K002365 | Datascope Reinforced Percutaneous Catheter Introducer Set | Datascope Corp. | DYB | Class II | |
| K002317 | Model 9000 Bariatric Wheelchair | Invacare GmbH | IOR | Class I | |
| K002287 | Wizair Compression System | Medical Compression Systems (Dbn), Ltd. | JOW | Class II | |
| K002277 | Fresenius Optiflux 200Nr | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K002271 | 2.4Mm Cortex Screw, Self-Tapping | Synthes (USA) Products LLC | HWC | Class II | |
| K002260 | Spina System | North American Medical Corporation (Nam) | ITH | Class II | |
| K002202 | Karman Wheelchair | Karman Healthcare Inc | IOR | Class I | |
| K002200 | Capella | Madsen Electronics, Inc. | EWO | Class II | |
| K002167 | Karman Wheelchair | Karman Healthcare Inc | IOR | Class I | |
| K002157 | Ranger II M6, Model in-888Wnl | Invacare GmbH | ITI | Class II | |
| K002129 | Ferris Polymem Sterile Wound Dressing with Collagen | Ferris Mfg. Corp. | MGQ | Unclassified | |
| K002100 | Ximx System | Medical Manager Research Development | LLZ | Class II | |
| K002070 | Biolok Screw | Biocomposites, Ltd. | HWC | Class II | |
| K002020 | Lactosorb Meniscal Screw | Biomet Manufacturing Corp | MAI | Class II | |
| K001991 | Titan Porocoat Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K001923 | Regency Power Wheelchair, Model 7200, 7500 & 7800 | Gendron, Inc. | ITI | Class II |