# K252518: DuoprossTM Smart Cap (Type I)

- Pathway: 510(k) (Traditional)
- Applicant: Duopross Meditech Corporate
- Decided: Dec 17, 2025 after 128 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861276 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210818: TrueCare Biomedix Tamper Evident Cap, Us Infusion Inc. D/B/A Truecare Biomedix-USA (2021) Summary page 5.

## Indications for use
Smart Caps are indicated for use as sterile tip caps with tamper-evident function for luer-lock syringes. The use time of the Smart cap should be ≤ 24 hours.

Source page: https://510kreport.com/device/K252518
Methodology: https://510kreport.com/methodology