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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K844479 | Chemspor | American Sterilizer Co. | FRC | Class II | |
| K854462 | Midas Rex Surgical Rubber Dam | Midas Rex Pneumatic Tools, Inc. | |||
| K854432 | Falkon Stretch | G.B.F. Industries, Inc. | EFQ | Unclassified | |
| K854420 | Meadox Surgimed a/s Three Piece Screw Biopsy Needl | Meadox Surgimed, Inc. | GDM | Class I | |
| K854341 | Delta-Lite Casting Resin | Johnson & Johnson Professionals, Inc. | LGF | Class I | |
| K854335 | Glucose Reagent Set (God/trinder) | Sterling Diagnostics, Inc. | CGA | Class II | |
| K854273 | Silicone Oil 350 Cnetistoke | Pacific Medical Industries | KRD | Class II | |
| K854240 | Calcitonin Ria Kit | Diagnostic Systems Laboratories, Inc. | JKR | Class II | |
| K854068 | External Mechanical Fastener | Wells Johnson Co. | |||
| K853795 | Kirschner Bipolar Endoprosthetic Head | Kirschner Medical Corp. | KWY | Class II | |
| K853524 | Apr Revision Hip Prosthesis, Femoral Component | Intermedics Orthopedics | KMC | Class II | |
| K853392 | Mon-a-Therm Subcutaneous Temp. Sensor | Mon-A-Therm, Inc. | FLL | Class II | |
| K851409 | Uniloc Total Hip Prosthesis | Serrano Intl. | |||
| K854258 | Playtex Light'n Gentle Unscented/deodorant/mini Ta | Intl. Playtex, Inc. | HIL | Class II | |
| K853944 | CPAP Blower | American Air & Process, Inc. | BTI | Class II | |
| K853777 | The New Mcintyre Cannula | MicroSurgical Technology Inc | HMX | Class I | |
| K854424 | Bard Parker 150Cc Bellows Reservoir | BD Becton Dickinson Vacutainer Systems Preanalytic | GCY | Class I | |
| K854423 | Immulon 1 Eia Tubes, Immulon 2 Eia Tubes | Dynatech Laboratories, Inc. | LIB | Class I | |
| K853766 | Alpha Super Kart | Alpha Unlimited, Inc. | INI | Class II | |
| K852637 | Thermo Trim | Suntec Health & Fitness Group, Inc. | IRT | Class II | |
| K854480 | Urinary Drainage Bag | The West Co., Inc. | KNX | Class II | |
| K854445 | Kirschner Bone Fixation Fastener System | Kirschner Medical Corp. | JDR | Class II | |
| K854418 | Round Suction Drain | Sil-Med Corp. | GBS | Class I | |
| K854408 | Adult Absorbent Incontinent Brief | Weyerhaeuser Co. | EYQ | Class I | |
| K854390 | Wire Cutting Pliers or Lineman's Pliers | Med-Tool, Inc. | HTC | Class I | |
| K854303 | Mr 700 Microplate Reader 012-700-1000 | Dynatech Laboratories, Inc. | JJQ | Class I | |
| K854301 | Pleur-Evac II Autotransfusion System | Deknatel, Inc. | CAC | Class II | |
| K854260 | Chempro 1000 | Sen Tech Medical Corp. | CGA | Class II | |
| K854243 | Es 22 | Boehringer Mannheim Corp. | JJE | Class I | |
| K854205 | Kirschner Compression Hip Screw System | Kirschner Medical Corp. | KTT | Class II | |
| K854055 | I.c.l.s. Compulyzer | Integrated Computerized Laboratory Systems, Inc. | JJG | Class I | |
| K854046 | Conical Collar Hip Prosthesis | Kirschner Medical Corp. | JDI | Class II | |
| K853852 | Multiscan 7 | Multiscan, Inc. | ITX | Class II | |
| K853845 | Alloy B | North American Alloys, Inc. | EJH | Class II | |
| K853768 | Muller Self Locking Total Hip | Protek, Inc. | JDI | Class II | |
| K853707 | Dicor Castable Ceramic-All Porcelain Bridges | Dentsply Intl. | EIH | Class II | |
| K853470 | Jumbo Digital Gammacamera Gca-90B Wi & W2 | Toshiba Medical Systems | IYX | Class I | |
| K853389 | Wallach Zoom Colposcope | CooperSurgical, Inc. | HEX | Class II | |
| K853326 | Water Driven Breast Pump by Baby Nurse | Baby Nurse | HGX | Class II | |
| K853107 | Axicare Cm-14 Automatic Breast Pump | Crystal Medical Products, Inc. | HGX | Class II | |
| K853055 | Light Cure Filling Material | Foremost Dental Mfg., Inc. | EBF | Class II | |
| K852910 | Cardiorater Cr7 | Cardiac Recorders, Ltd. | DRT | Class II | |
| K852652 | Omnigraph 4000(Electrocardiograph) | Telemed Div. | DRS | Class II | |
| K851735 | Sys Stim 206 Model Me206 | Mettler Electronics Corp | GZJ | Class II | |
| K851625 | Scx-10 Single Channel Recorder Access. for G-2000 | Eaton Medical Group | DSF | Class I | |
| K851244 | Greco-Harvey Surfactant Bonded Cath for Anesthesio | Cook, Inc. | KDQ | Class II | |
| K854457 | Columbia Cna Agar W/5% Sheep Blood | R. Kent Richards, Inc. | JSJ | Class I | |
| K854456 | Campylobacter Blood Agar | R. Kent Richards, Inc. | JSJ | Class I | |
| K854455 | Cdc Anaerobe Blood Agar | R. Kent Richards, Inc. | JSG | Class I | |
| K854454 | Tryptic Soy Blood Agar | R. Kent Richards, Inc. | KZI | Class I |