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 |
|---|---|---|---|---|---|
| K960036 | Firard II/ Tdp Lamp | Helio Medical Supplies, Inc. | ILY | Class II | |
| K954131 | Hoveround Power Wheelchair or Hvr-200 by Hoveround | Hoveround Corp. | ITI | Class II | |
| K961189 | Tas a Ptt Test Controls | Cardiovascular Diagnostics, Inc. | GGN | Class II | |
| K961113 | Cns Interchangeable Bit Cranial Drill | Clinical Neuro Systems, LLC | HBG | Class II | |
| K961020 | Steri-Oss 6Mm Diameter Tps Coated Implants | Steri-Oss, Inc. | DZE | Class II | |
| K960937 | Suction Safety Device | R D Intl. | MJJ | Class II | |
| K960900 | Imcor 3.75 Mm Wide Hex Self-Tapping Screw W/cover Screw | Imcor | DZE | Class II | |
| K960676 | Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004 | ZOLL Medical Corporation | DTE | Class II | |
| K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos) | Somanetics Corp. | DQA | Class II | |
| K960438 | Tintelize Pai-1 Kit | Medical Diagnostic Technologies, Inc. | GGP | Class II | |
| K960045 | Envirotex Reusable o.r. Wrapper and Custom Surgical Drape | The Sewing Source, Inc. | KKX | Class II | |
| K955776 | Acu-Lab | Glederer & Co., Inc. | LDQ | ||
| K955181 | u.s. Endoscopy Group, Inc. Balloon Replacement Gastrostomy Tube | United States Endoscopy Group, Inc. | KNT | Class II | |
| K954605 | Ace Cylinder Dental Implant | Ace Surgical Supply Co., Inc. | DZE | Class II | |
| K954513 | Ace Srew Dentla Implant System | Ace Surgical Supply Co., Inc. | DZE | Class II | |
| K954063 | Glove Seal & Set-Rite | Contract Latex Dippers Sdn Bhd | LYY | Class I | |
| K950829 | Mardx Lyme Disease (Igg) Marblot Strip Test System | Mardx Diagnostics, Inc. | LSR | Class II | |
| K950806 | Solid Dilicone Implants, Sdilicone Sponge Implants | Mira, Inc. | HQX | Class II | |
| K942525 | Medicount Deka Hematology Analyzer | Cea America Corp. | GKZ | Class II | |
| K962031 | Quantec Series 2000 Endodontic Files | Tycom Dental | EKS | Class I | |
| K960987 | Liquichek Rheumatoid Factor Control | Bio-Rad | DHR | Class II | |
| K960957 | External Power Source (Eps) System, Power Pack | Sims Deltec, Inc. | FRN | Class II | |
| K960924 | Kowa Hand-Held Applanation Tonometer Ha-1 | Kowa Pharmaceuticals America, Inc. | HKY | Class II | |
| K960916 | Sams 8000 Cardioplegia Monitor | 3M Health Care, Sarns | DSJ | Class II | |
| K955182 | Nipro Arterial Venous Fistula Needle | Nissho Corp. | FIE | Class II | |
| K954798 | 7100 Swallowing Workstation | Kay Elemetrics Corp. | KLA | Class II | |
| K953681 | Haemonetics Therapeutic Plasma Exchange Set | Haemonetics Corporation | LKN | Unclassified | |
| K961724 | U-Doa Controls | Medical Diagnostic Technologies, Inc. | DIF | Class I | |
| K961437 | Wheeled Stretcher | Hill-Rom Inc. | FPO | Class II | |
| K961431 | Lactate Dehydrogenase Reagent Set | Horiba Instruments Incorporated | CFJ | Class II | |
| K961351 | Hcg Er Method for the Technicon Immuno 1 System in-Vitro Diagnostic Clinical Method | Bayer Corp. | DHA | Class II | |
| K961136 | Pulsemaster | American Dental Technologies, Inc. | GEX | Class II | |
| K961097 | Electrosurgical Cutting & Coagulation Device & Accessories | Debusk Knitting Mills, Div. Deroyal Industries | GEI | Class II | |
| K960941 | Upacs | Base Ten Systems, Inc. | LMB | Class I | |
| K960905 | Sdl Diode Laser System | Slt-J, Ltd. | GEX | Class II | |
| K960892 | The Cobalt Scalpel | Nova Therapeutic System | IWB | Class II | |
| K960086 | Dcl8 Enhanced Pulsed Nd:yag Laser System | Slt-J, Ltd. | GEX | Class II | |
| K955687 | Rns Sterile, Disposable Radiographic Contrast Tray | Contour Fabricators of Florida, Inc. | JAA | Class II | |
| K955258 | 3030 Infusion Pump | Sabratek Corp. | FRN | Class II | |
| K961485 | Forefoot Reconstruction System | Howmedica Corp. | HRS | Class II | |
| K961713 | Instrument Set for Arthroscopic Percutaneous Discectomy | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K961712 | Tbd at-Home Pregnancy Test | Armkel, LLC | LCX | Class II | |
| K961660 | Tongue Cleaner | Jack Conrey | LCN | Class I | |
| K961537 | Sas Shigella Sonnei Form II Antiserum | SA Scientific, Ltd | GNB | Class II | |
| K961452 | Lyofoam Extra 'a' Sterile Adhesive Wound Dressing | Acme United Corp. | KMF | Class I | |
| K961440 | Surgical Patch, Surgical Membrane, Surgical Mesh | Fusion Medical Technologies, Inc. | FTL | Class II | |
| K961266 | Accusign, Biosign Pcp | Princeton BioMeditech Corp. | LCM | Unclassified | |
| K961147 | Closed Fluid Collection System | B.Braun Medical, Inc. | GBX | Class I | |
| K961146 | Sunglasses | Erica Optical Co. | HQY | Class I | |
| K961063 | As/3 Cardiac Output & Svo2 Module | Datex Medical Instrumentation, Inc. | DQK | Class II |