# K231095: Tamper Evident Cap

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Industries, Inc.
- Decided: Sep 4, 2024 after 505 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.
No later device cites it as a predicate yet.
0 of 2 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.

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

Source page: https://510kreport.com/device/K231095
Methodology: https://510kreport.com/methodology