# K110993: Femchec Pressure Managemet Device

- Pathway: 510(k) (Traditional)
- Applicant: Femasys, Inc.
- Decided: Oct 12, 2011 after 187 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 K000704 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
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 2.
- K792134: Bonchek-Shiley Vein Distention System, Shiley, Inc. (1979) Summary page 2.
- K082725: Graftguard Pressure Controlling Syringe, Maquet Cardiovascular, LLC (2008) Summary page 2.

## Indications for use
The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg. The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.

Source page: https://510kreport.com/device/K110993
Methodology: https://510kreport.com/methodology