# K210818: TrueCare Biomedix Tamper Evident Cap

- Pathway: 510(k) (Traditional)
- Applicant: Us Infusion Inc. D/B/A Truecare Biomedix-USA
- Decided: Sep 15, 2021 after 181 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: 2 generations back to K861276 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193192: Tamper Evident Cap, International Medical Industries, Inc. (2020) Summary page 4.

## Most influential descendants
- K252518: DuoprossTM Smart Cap (Type I) (2025), 0 descendants of its own

## Indications for use
Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.

Source page: https://510kreport.com/device/K210818
Methodology: https://510kreport.com/methodology