Duopross Meditech Corporate · Class II · Cleared Dec 17, 2025
| K-number | K252518 |
| Device name | DuoprossTM Smart Cap (Type I) |
| Applicant | Duopross Meditech Corporate |
| Product code | FMF |
| Device class | Class II |
| Decision date | Dec 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5860 |
The DuoprossTM Smart Cap (Type I) is a sterile, tamper-evident syringe cap designed for use with luer-lock syringes. It features a clear outer shell that separates upon opening to provide visual confirmation that the cap has not been removed, with a maximum use time of 24 hours.
The device is a female luer-lock cap made of acrylonitrile butadiene styrene (ABS) with blue color additive and polypropylene (non-patient contacting). It is sterilized via ethylene oxide to a Sterility Assurance Level of 10⁻⁶, is single-use, and provides indirect blood contact for limited duration (<24 hours).
ISO 80369-7 (small-bore connectors), ISO 10993-1 (biocompatibility classification), ISO 11135 (ethylene oxide sterilization validation), ISO 10993-7 (EO residual testing), ISO 11607-1 and 11607-2 (packaging integrity), ASTM F1886, F1929, F88/F88M, D4169, and F1980 (packaging and shipping performance).
The Smart Cap is substantially equivalent to the TrueCare Biomedix Tamper Evident Cap (K210818) because both are female luer-lock tamper-evident caps with identical fundamental technology, sterility levels, single-use designation, and indications. Differences in material composition and specific indication language do not raise new safety or effectiveness concerns, and the device meets all applicable biocompatibility and sterilization standards.
View the full FDA submission: accessdata.fda.gov