# K142545: SonoFlow Sonohysterography and Sonohysterosalpingography Device

- Pathway: 510(k) (Traditional)
- Applicant: Crossbay Medical, Inc.
- Decided: Mar 20, 2015 after 191 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 4.
- K083690: Femvue (TM) Catheter System, Femasys, Inc. (2009) Summary page 4.

## Indications for use
The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill saline-only or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.

Source page: https://510kreport.com/device/K142545
Methodology: https://510kreport.com/methodology