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 |
|---|---|---|---|---|---|
| K944846 | Auraflex B2-Microglobulin | bioMerieux, Inc. | JZG | Class II | |
| K944128 | Caltag Cd4 R-Pe Monoclonal Antibody | Caltag Laboratories, Inc. | GKZ | Class II | |
| K944127 | Caltag Cd3 Fitc, R-Pe, Tri-Color Monoclonal Antibody | Caltag Laboratories, Inc. | GKZ | Class II | |
| K944126 | Caltag Cd8 Fitc and Cd8 R-Pe Monoclonal Antibodies | Caltag Laboratories, Inc. | GKZ | Class II | |
| K930353 | Simmons Plating System Bolt and Screw | Smith & Nephew, Inc. | MNH | Class II | |
| K952441 | Legend | Health Care Mfg., Inc. | INQ | Class I | |
| K952229 | Widex Model Logo 32 (L32) | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K951817 | Eli Urine Controls | Elsohly Labs, Inc. | DIF | Class I | |
| K951659 | Zomed Model 10 Cautery Biopsy Device | Zomed Intl. | GEI | Class II | |
| K951356 | Various Uhmwp Hip & Knee Joint Prosthesis Modified | Biologically Oriented Prostheses | LPH | Class II | |
| K951332 | Paramax Alanine Aminotransferase (Gpt) Reagent | Dade Intl., Inc. | CKA | Class I | |
| K951145 | Vmi 1000 Surgical Paceometer | Vision Medical Instruments, Inc. | ITX | Class II | |
| K951143 | Pulse Klystron Amplififer (L-5822-90) | Litton Systems, Inc. | IYE | Class II | |
| K951059 | Ciba Corning Acs Vancomycin Immunoassay | Ciba Corning Diagnostics Corp. | LEH | Class II | |
| K950639 | Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers | Karl Storz Endoscopy-America, Inc. | MOK | Class II | |
| K950258 | Hemo-Barrier Tourniquet | Hemo-Barrier Technologies, Inc. | EFQ | Unclassified | |
| K945582 | Witt Biomedical Image III | Invivo Corporation | LLZ | Class II | |
| K945515 | Coated Tungsten Eyeshield | Medtec LLC | IWS | Class I | |
| K945468 | T-300 Cooler | Temptek, Inc. | ILO | Class II | |
| K944750 | Corflo 300 Pump | Corpak Co. | FRN | Class II | |
| K944070 | Advanced Nmr Syst Instascan/modif: T1 & Te Stepping | Advanced Nmr Systems, Inc. | LNH | Class II | |
| K941666 | Signa Advantage Magnetic Resonance System-Hispeed Performance Options | General Electric Co. | LNH | Class II | |
| K932033 | Laparoscopic Surgery Instruments | Medline | GCJ | Class II | |
| K926363 | Multi-Dop S | Dantec Medical, Inc. | IYO | Class II | |
| K952632 | S-Scort | Sscor | BTA | Class II | |
| K952499 | Vs1 Plus | Metalor Dental USA Corp. | EJT | Class II | |
| K952481 | Richards Porp | Smith & Nephew Richards, Inc. | ETB | Class II | |
| K952456 | Image Intensified Fluoroscopic X-Ray System | Fisher Imaging Corp. | JAA | Class II | |
| K952402 | Aurium 68M | Argen Precious Metals, Inc. | EJT | Class II | |
| K952233 | Clear-Pb Lead Plastic Overhead Barrier 56-628 | Victoreen, Inc. | EAK | Class I | |
| K952227 | C-Flex Endolymphatic Shunt | Trebay Medical Corp. | ESZ | Class II | |
| K951730 | Spyrofoam Wound Dressing | Polymedica Industries, Inc. | KMF | Class I | |
| K951522 | Woodbine/solos Vcm-3, High Resolution One-Chip Surgical Camera | Woodbine Optical Corp. | GCJ | Class II | |
| K951509 | Pulse*spray Infusion System | Angiodynamics, Div. E-Z-Em, Inc. | QEY | Class II | |
| K951304 | Synthes 2.7 Mm Cannulated Screw and Threaded Washer | Synthes (USA) Products LLC | HWC | Class II | |
| K951142 | Pulse Klystron Amplifier (L-5822-00) | Litton Systems, Inc. | IYE | Class II | |
| K951115 | Howmedica Vitalock 22Mm Acertabular Shell and System 12 Inserts | Howmedica Corp. | LPH | Class II | |
| K951114 | System 12 P1 26Mm Acetabular Insert | Howmedica Corp. | LPH | Class II | |
| K950521 | Osteonics All Polyethylene Glenoid Shoulder Component | Osteonics Corp. | KWS | Class II | |
| K950499 | Nezhat-Dorsey Laparoscopic Hand Instruments | American Hydro-Surgical Instruments, Inc. | KNF | Class II | |
| K946041 | Cardico Sharps Containers (1.5, 5, 9, 13, 21Qts.) | Cardico, Inc. | FMI | Class II | |
| K946039 | Model #5000 Pulmo Plus | International Medical Systems | BTI | Class II | |
| K943709 | Dinamap Plus Vital Signs Monoitor | Critikon Company, LLC | DPS | Class II | |
| K943626 | Isolyser Sharps Management System Sms | Thantex Specialties, Inc. | FMI | Class II | |
| K941843 | Mms-2400 | Parvo Medics Inc. | BZC | Class II | |
| K932985 | Aromatic Condom, Essentials, Mi Vida & Jiffi | Sime Health, Ltd. | HIS | Class II | |
| K930521 | Air Cleaners with Hepa Filtration | The Rival Co. | FRF | Class II | |
| K952573 | Rusch Urodynamic Rectal Balloon Catheter | Rusch Intl. | FEN | Class II | |
| K952149 | Karl Storz Take-Apart Rotating Grasping Forceps | Karl Storz Endoscopy-America, Inc. | LQR | Class II | |
| K951906 | Cardon Physical Therapy Tables Models R28591 & R28592 | Cardon Rehabilitation Products, Inc. | INQ | Class I |