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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K893604 | TENS Prep | Smith & Nephew United, Inc. | GYB | Class II | |
| K893393 | Epo-Trac by Radioimmunoassay (Ria) | Incstar Corp. | GGT | Class II | |
| K892922 | Latex Surgical Gloves | Millimax Corp. | KGO | Class I | |
| K892892 | Net Stretcher Pad (Tm) | North East Technology | FPP | Class I | |
| K892659 | Electrodelca | Oldelft Corp. of America | IZG | Class II | |
| K890058 | Vascular Technology Uniox Oxygen Alarm | Vascular Technology Incorporated | CCL | Class II | |
| K884824 | Tricon-M Total Knee System | Richards Medical Co., Inc. | MBV | Class II | |
| K896462 | Nova Gel(tm) T Jo-1 | Inova Diagnostics, Inc. | LLL | Class II | |
| K896461 | Nova Gel(tm) T Scl-70 | Inova Diagnostics, Inc. | LLL | Class II | |
| K896460 | Nova Gel(tm) T Ss-A/ss-B | Inova Diagnostics, Inc. | LLL | Class II | |
| K896459 | Nova Gel(tm) T Sm/rnp | Inova Diagnostics, Inc. | LLL | Class II | |
| K896310 | Acufex Fixation Button; Retention Bar, Wedge | Acufex Microsurgical, Inc. | KGS | Class I | |
| K896204 | Zirconia Ceramic Head Add'l Sizes | Richards Medical Co., Inc. | LZO | Class II | |
| K895684 | Soft Suction Adapter | Applied Medical Technologies | GEA | Class I | |
| K893040 | Orthomet Plus Total Knee Syst, Titanium Tibial Peg | Orthomet, Inc. | JWH | Class II | |
| K896222 | Free Thyroxine (Ft4) Radioimmunoassay Kit | Nichols Institute Diagnostics | CEC | Class II | |
| K896116 | Entrapping Filter | Cadema Medical Products, Inc. | CAH | Class II | |
| K896088 | Femoral Angiography Drape | Medical Plastics, Inc. | IZI | Class II | |
| K896074 | Vision Phenytoin | Abbott Medical | DIP | Class II | |
| K896036 | The Comfortable Cannula | Comfortable Concepts Corp. | CAT | Class I | |
| K895871 | Lifeport Polyurethane Catheter | Strato Medical Corp. | LJT | Class II | |
| K895794 | Ge Mr Max System | GE Healthcare | LNH | Class II | |
| K895716 | Latex Patient Examination Gloves | Lizhu Sanitary Materials Factory | LYY | Class I | |
| K895607 | Porous Coated Total Hip Pros. Acetabular Component | Exactech, Inc. | JDL | Class III | |
| K895557 | Patient Examination Gloves | Moeller Chemicals, Inc. | LYY | Class I | |
| K895467 | Orthophos and Orthophos C | Siemens Medical Solutions USA, Inc. | EHD | Class II | |
| K895245 | Flexible Fiber-Optic Nasopharyngoscope | Optimed Technologies, Inc. | EOB | Class II | |
| K895242 | Pappas Tri-Flange Ventilation Tube | Richards Medical Co., Inc. | ETD | Class II | |
| K895164 | Eagle Ds | American Sterilizer Co. | ECG | Class I | |
| K894965 | Porous-Coated Titanium Acetabular Cup | Dow Corning Wright | JDL | Class III | |
| K894604 | Biopro Proximal Femoral Articular Replacement | Biopro, Inc. | KXA | Class II | |
| K894402 | Hipgraphics System One W/orthotool | Hipgraphics, Inc. | LLZ | Class II | |
| K893351 | Latex Examination Gloves (Mfg. Anhui Bengbu Latex) | China National Medicines & Health Prod. I/E Corp. | LYY | Class I | |
| K893124 | Olympus Pk(tm) Tp | Fujirebio Diagnostics, Inc. | GMT | Class II | |
| K893038 | Protofluor Z | Helena Laboratories, Corp. | JKJ | Class I | |
| K892855 | Urethral Balloon Dilation Catheter Set | Cook Incorporated | KOE | Class II | |
| K892342 | Tec 2750 Phoenix Dedicated Mammographic System | Bay Shore Medical Equipment, LLC | IZH | Class II | |
| K891259 | Model 4000 Alternating Pressure Pump and Pad | Diamond Medical Equipment, Inc. | FNM | Class II | |
| K890978 | Target Opiates-R | V-Tech, Inc. | DJG | Class II | |
| K890754 | Sporview Culture Media | Spsmedical Supply Corp. | FRC | Class II | |
| K871877 | Ideia Herpes Simplex Virus Test | Boots-Celltech Diagnostics, Inc. | LGC | Class II | |
| K896434 | Auto Suture Surgiport Cannula Diameter Reducer* | United States Surgical, A Division of Tyco Healthc | GEA | Class I | |
| K895499 | Poly-Flex Latex Examination Gloves | Pacific Delta Medical Supply | LYY | Class I | |
| K895459 | Latex Patient Examination Gloves | The Emulision Glove Factory of the Thirteenth | LYY | Class I | |
| K895340 | Abtex or Jutamal Latex Examination Gloves | Jutamal Industry | LYY | Class I | |
| K895247 | Model Ir103 Surgical Laser System | Niic U.S.A., Inc. | GEX | Class II | |
| K895239 | Model Ir107 50-Watt Carbon-Dioxide Surgical Laser | Niic U.S.A., Inc. | GEX | Class II | |
| K895227 | Skintex Latex Examination Gloves | Fabrica de Plasticos Mexicanos del Sur. S.A. | LYY | Class I | |
| K895194 | Latex Patient Examination Gloves | Waterwide Sdn. Bhd. | LYY | Class I | |
| K895023 | Latex Patient Examination Glove | Beijing Latex Factory | LYY | Class I |