# K861276: Tamper Proof Cap

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Medical Industries
- Decided: May 5, 1986 after 28 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
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K193192: Tamper Evident Cap (2020), 2 descendants of its own
- K210818: TrueCare Biomedix Tamper Evident Cap (2021), 1 descendant of its own
- K252518: DuoprossTM Smart Cap (Type I) (2025), 0 descendants of its own
- K231095: Tamper Evident Cap (2024), 0 descendants of its own
- K182545: Tamper Evident Cap with Male Luer Lock (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K861276
Methodology: https://510kreport.com/methodology