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 |
|---|---|---|---|---|---|
| K853304 | 21 Hematology Reagents | In Vitro Diagnostics, Inc. | GKZ | Class II | |
| K853290 | Techna Vision Auto-Perimeter | Techna Vision | HPT | Class I | |
| K853019 | Nitroglycerin Infusion Set | Lyphomed, Inc. | FPA | Class II | |
| K852932 | Measles-Complement Fix Antigen & Negative Clt | Microbix Biosystems, Inc. | GRF | Class I | |
| K852931 | Herpes Hominus I-Comple Fix Antigen & Negative Clt | Microbix Biosystems, Inc. | GQO | Class II | |
| K852930 | Varicella-Zoster-Comple Fix Antigen and Neg Contro | Microbix Biosystems, Inc. | GQX | Class II | |
| K852929 | Cmv-Complement Fixation Antigen and Negative Contr | Microbix Biosystems, Inc. | GQI | Class II | |
| K852790 | Analyzer: Nova Stat Profile 1 Qua Con Mat: Elect | Nova Biomedical Corporation | CHL | Class II | |
| K851425 | Model J25-25 Watt CO2 Laser | Britt Corp., Inc. | HHR | Class II | |
| K843628 | Hotip Hemostatic Probe | Trimedyne, Inc. | LNK | Class II | |
| K854348 | Churchill 3-Way Stopcock Set | Churchill Corp. | FMG | Class II | |
| K854224 | Golden Rule Sun Tanning Beds | Golden Rule Tanning Co., Inc. | FTC | Class II | |
| K854170 | I.s.m. Product Family Model R3600c | Intl. Solarium Manufacturer, Inc. | FTC | Class II | |
| K854154 | Fox Bed Model 2001 | Ace Mfg. | FTC | Class II | |
| K854131 | Phase V-Model 1500 Ruva | Apollo'S Suntanning Supplies | FTC | Class II | |
| K854111 | Express Tan Sun Canopy | Sunmaker Tanning Systems, Ltd. | FTC | Class II | |
| K854084 | Pediatric Hemodialysis Replacement Pump Segment | bioMerieux, Inc. | FKL | Class II | |
| K854007 | Microtherm Mt-501 & Mt-502 | Medequi, Division of King Yip Co., Inc. | FLL | Class II | |
| K853970 | Alpha Chuck | Rocky Mountain Medical Corp. | KME | Class I | |
| K853824 | Digital Thermometer | Epson America, Inc. | FLL | Class II | |
| K853444 | Toshiba Tct-900S Computed Tomography CT X-Ray Sys | Toshiba Medical Systems | JAK | Class II | |
| K853381 | Oe Series of Behind-the-Ear Hearing Aids | Emtech Laboratories | ESD | Class I | |
| K853130 | Integrated Display Technology Ltd. | Integrated Display Technology, Ltd. | FLL | Class II | |
| K852943 | Neo Shield | Gaymar Industries, Inc. | FMT | Class II | |
| K852534 | Ultraviolet Treatment Lamps UV-8 & UV-9 | R. A. Fischer Co. Corp. | FTC | Class II | |
| K852340 | Suprima Model 254-24 | Intermedics, Inc. | DXY | Class III | |
| K852339 | Suprima Model 254-22 | Intermedics, Inc. | DXY | Class III | |
| K851632 | Pcx-100 Patient Input Leadwire | Eaton Medical Group | DRW | Class II | |
| K851627 | Kbx-20 Outboard Keyboard Access. for G-2000 Electr | Eaton Medical Group | DRW | Class II | |
| K841960 | Cardio Metrics Invasive Pressure Monit | Sterile Design, Inc. | DRS | Class II | |
| K854062 | Pall Pulmonary Function Filter | Pall Biomedical Products Co. | BZG | Class II | |
| K854042 | Resin Tray Impression Material | Dentsply Intl. | EBH | Class I | |
| K853982 | Golden Ceramic | Wiliams Gold Refining Co., Inc. | EJT | Class II | |
| K853781 | Unitron Model Um60-Pp | Unitron Industries, Inc. | ESD | Class I | |
| K853780 | Unitron Model Um60-D | Unitron Industries, Inc. | ESD | Class I | |
| K853630 | Believe Heavy Flow Protection Labial Pads | Kimberly-Clark Corporation | HHD | Class I | |
| K853607 | Allerg-E Ige Enzyme Immunoassay Kit | Dexall Biomedical Labs, Inc. | DGO | Class II | |
| K853579 | Medipart Dispos. Xenon 133 Admin. Sys Mp-0133 | Medipart Jerry Alexander | IYT | Class II | |
| K853576 | Medipart Dispos. Xenon 133 Admin. Set Mp-0133M | Medipart Jerry Alexander | IYT | Class II | |
| K853570 | Medipart Drierite Mp-1002 | Medipart Jerry Alexander | IYT | Class II | |
| K853569 | Medipart Corrugated Polyethylene & E.v.a. Tubing | Medipart Jerry Alexander | BYX | Class I | |
| K853523 | Visible Light Cured Orthodontic Adhesive | Dentsply Intl. | DYH | Class II | |
| K853416 | Mes-Tens(tens) | Oriental Medical Supplies, Inc. | GZJ | Class II | |
| K853279 | Coxsackie A2 Cf Antigen, A4, A10 & A16 | Hillcrest Biologicals | GNO | Class I | |
| K853278 | Polio Type I Cf Antigen, & Type II, III | Hillcrest Biologicals | GOG | Class I | |
| K853277 | Cmv Cf Antigen | Hillcrest Biologicals | GQI | Class II | |
| K853179 | Vickers Ergomatic Microsur Instru-Univ R O L Hand | Keeler Instruments, Inc. | GZX | Class I | |
| K853165 | Echo Type 30 Cf Antigen | Hillcrest Biologicals | GNK | Class I | |
| K853161 | The Vickers Standard Microsurgery Set | Keeler Instruments, Inc. | GZX | Class I | |
| K853157 | Echo Type 11 Cf Antigen | Hillcrest Biologicals | GNK | Class I |