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 |
|---|---|---|---|---|---|
| K934065 | Medtronic Mattrix 3271/3272 Neurostimulation System | Medtronic, Inc. | GZB | Class II | |
| K932024 | Ccg Cerclage System | Encore Orthopedics, Inc. | JDQ | Class II | |
| K950336 | Karl Storz Adapters for Documentation Purposes | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K950318 | Flex Blue | King Systems Corporation. | CBH | Class I | |
| K946243 | Conveen(r) Self-Sealing Urisheath Male External Catheter | MEDLINE INDUSTRIES, LP - Northfield | EXJ | Class I | |
| K946235 | Conmed 7/8Mm Gasket Reducer for Use with Trogard(tm) Trocar Sleeve | Conmedcorp | HET | Class II | |
| K945899 | Gore-Tex(r) Curved Surgicalmembrane | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K945835 | Argidene(tm) Gel | Telios Pharmaceuticals, Inc. | MGQ | Unclassified | |
| K945834 | Prophy Pro. | Hyman, Phelps & McNamara, P.C. | EGS | Class I | |
| K945686 | Karl Storz Knives, Curettes | Karl Storz Endoscopy-America, Inc. | EZO | Class II | |
| K945617 | Pharma-Plast Pureline(tm) Basic(tm) and Pureline(tm) Contact(tm) Subcutaneous Infusion Sets | Pharma-Plast Intl. A/S | FPA | Class II | |
| K945583 | Ocusystem(art) | Arent Fox | HQC | Class II | |
| K945497 | B-D Durasafe)tm) Variable Extension Combined Spinal Epidural *Cse) Needle Set/kit | BD Becton Dickinson Vacutainer Systems Preanalytic | CAZ | Class II | |
| K945167 | Dj Medical Pneumatic Tourniquet | DJ Medical, Inc. | KCY | Class I | |
| K945158 | Micro-Touch Lp Latex Surgical Gloves | Johnson & Johnson MEDICAL GmbH | KGO | Class I | |
| K945157 | Maxxus Lp Orthopaedic Latex Surgical Gloves | Johnson & Johnson MEDICAL GmbH | KGO | Class I | |
| K943674 | Neutralon Lp Brown Latex Surgical Gloves | Maxxim Medical | KGO | Class I | |
| K943397 | Dsl Active Aldosterone Ria (Dsl 8600) | Diagnostic Systems Laboratories, Inc. | CJM | Class II | |
| K942667 | Dent-O-Cryl Orthodontic Acrylic | Dentauraum, Inc. | KMY | Class I | |
| K941298 | Iumc Endometrial Sampler | Cook Ob/Gyn | HFE | Class II | |
| K935844 | Gip/medi-Globe Needle System for Ultrasonic Fna | Medi-Globe GmbH | FCG | Class II | |
| K933596 | Gastric, Catheter, Irrigation & Aspiration | Polamedco, Inc. | BSS | Class II | |
| K926379 | Altra Nova 200 Hemodailyzer | Althin Medical AB an Affiliate of Baxter Intl | KDI | Class II | |
| K926373 | Altra Flux 200 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | KDI | Class II | |
| K926372 | Mca 200 Hempdialyzer | Althin Medical AB an Affiliate of Baxter Intl | FJI | Class II | |
| K926354 | Endo-Pore Endosseous Dental Implant System | Innova Corp. | DZE | Class II | |
| K924972 | Sonamet Body Composition Analyzer | Life Measurement Instruments, Inc. | OAC | Class II | |
| K922757 | Sps 1550 Single Needle Patient System | Baxter Healthcare Corporation | FKP | Class II | |
| K950380 | Flextitip Stylette | Polamedco, Inc. | BSR | Class I | |
| K950364 | Cardon Physical Therapy Tables R27635 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950363 | Cardonphysical Therapy Table R27110 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950362 | Cardon Physical Therapy Table R27114 and R27642 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950361 | Cardon Physical Therapy Table R28575 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950360 | Cardon Physical Therapy Table Model R28535 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950188 | Valleylab Coated Electrodes | Medtronic, Inc. | GEI | Class II | |
| K950116 | Therasteam Personal Steam Inhaler | Kaz, Inc. | KFZ | Class I | |
| K950060 | Provilink | Ivoclar North America, Inc. | EMA | Class II | |
| K950059 | Mc Infant Care Unie #Pp30 | Janco Consulting Services | FMS | Class II | |
| K950058 | Mc Healthcare #Ch31 Child's Crib | Janco Consulting Services | FMS | Class II | |
| K950051 | Brewer Company Teddy Crib Model 71900-a, B, 71910-a, B | The Brewer Company LLC | FMS | Class II | |
| K946336 | Megabeam Fiber Optic Delivery System | Hogan & Hartson | GEX | Class II | |
| K946266 | Ferritin Control - Level 1, 2, 3 | Clinical Controls, Inc. | DGD | Class II | |
| K946210 | Phenobarbital Enzyme Immunoassay | Diagnostic Reagents, Inc. | DLZ | Class II | |
| K946050 | Liquispex(tm) Liquid Crp Control Level 1 and 2 | Clinical Controls, Inc. | DCK | Class II | |
| K946049 | Liquispex(tm) Liquid B2m/crp Control Level 1 and 2 | Clinical Controls, Inc. | JJY | Class I | |
| K946048 | Liquispex(tm) Liquid B2m Control Level 1 and 2 | Clinical Controls, Inc. | JZG | Class II | |
| K945966 | Alko Calibrators and Flush Solution for Il 1300 Series Ph/blood Gas Analyzers | Alko Diagnostic Corp. | JIX | Class II | |
| K945608 | Abusign(tm) Opi, Doa-Opi, Accusign(tm) Opi, Doa-Opi, Biosign(tm) Opi, Doa-Opi | Princeton BioMeditech Corp. | DJG | Class II | |
| K945591 | Applied Medical Optical Valvulotome | Applied Medical Resources Corp | LYK | Class II | |
| K945588 | Disposable 1Cc Syringe with Luer Lock | Interventional Therapeutics Corp. | FMF | Class II |