# K242002: FemVue MINI Saline-Air Device

- Pathway: 510(k) (Traditional)
- Applicant: Femasys, Inc.
- Decided: Nov 22, 2024 after 136 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K881680 (1988). 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)
- K110288: Femvue Saline-Air Device, Femasys, Inc. (2011) Summary page 5.

## Indications for use
FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

Source page: https://510kreport.com/device/K242002
Methodology: https://510kreport.com/methodology