# K200425: Female Luer Lock Cap

- Pathway: 510(k) (Traditional)
- Applicant: Medsafety Solutions, LLC
- Decided: Oct 29, 2020 after 252 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The Female Luer Lock Cap is indicated for use as a cap for male Luer fittings on medical devices such as manifolds, stopcocks or IV sets.

Source page: https://510kreport.com/device/K200425
Methodology: https://510kreport.com/methodology