# K110288: Femvue Saline-Air Device

- Pathway: 510(k) (Traditional)
- Applicant: Femasys, Inc.
- Decided: Apr 28, 2011 after 86 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: 2 generations back to K881680 (1988). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020954: H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray & Multipurpose Procedure Tray, Ackrad Laboratories (2002) Summary page 1.

## Most influential descendants
- K241693: FemChec Controlled Saline-Air Device (FCD-250) (2024), 1 descendant of its own
- K253403: FemVue® Controlled Saline-Air Device (FSA-300) (2025), 0 descendants of its own
- K242002: FemVue MINI Saline-Air Device (2024), 0 descendants of its own
- K142545: SonoFlow Sonohysterography and Sonohysterosalpingography Device (2015), 0 descendants of its own
- K143415: Air Bubble Based Infuser (ABBI) (2015), 0 descendants of its own

## Indications for use
The FemVueTM Saline-Air Device instills 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/K110288
Methodology: https://510kreport.com/methodology