# K180135: THD Anopress with THD SensyProbe

- Pathway: 510(k) (Traditional)
- Applicant: Thd Spa
- Decided: Mar 8, 2018 after 50 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931574 (1993). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161785: THD Anopress, Thd Spa (2017) Summary page 4.
- K120088: Mcompass Anorectal Manometry System, Medspira, LLC (2012) Summary page 4.

## Most influential descendants
- K242666: Fecobionics Anorectal System (2025), 0 descendants of its own
- K242304: RED (2024), 0 descendants of its own
- K211623: THD Procto Software System (2021), 0 descendants of its own

## Indications for use
The THD Anopress device must be used exclusively to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal on the specially designed THD Probes. THD Anopress must only be used by appropriately trained medical staff. Furthermore, the THD SensyProbe enables evaluation of rectal sensitivity and capacity and the ano-rectal inhibitory reflex through connection to a syringe and filling of the balloon on the probe with air. The THD Anopress with THD SensyProbe is intended to be used in adults only.

Source page: https://510kreport.com/device/K180135
Methodology: https://510kreport.com/methodology