# K182545: Tamper Evident Cap with Male Luer Lock

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Industries, Inc.
- Decided: Jan 11, 2019 after 116 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K981318 (1998). 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)
- K101385: Dual Luer Lock Cap, Model 2C6250, Baxter Healthcare Corp (2010) Summary page 4.
- K861276: Tamper Proof Cap, Intl. Medical Industries (1986) Summary page 4.

## Indications for use
The Tamper Evident Cap with Male Luer Lock is indicated for use as a cap for female Luer ports on medical devices such as manifolds, stopcocks or set.

Source page: https://510kreport.com/device/K182545
Methodology: https://510kreport.com/methodology