# K193192: Tamper Evident Cap

- Pathway: 510(k) (Special)
- Applicant: International Medical Industries, Inc.
- Decided: Jan 31, 2020 after 73 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: 1 generation back to K861276 (1986). 1 ancestor in all.
2 later devices descend 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)
- K861276: Tamper Proof Cap, Intl. Medical Industries (1986) Summary page 4.

## Most influential descendants
- K210818: TrueCare Biomedix Tamper Evident Cap (2021), 1 descendant of its own
- 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/K193192
Methodology: https://510kreport.com/methodology