# K161785: THD Anopress

- Pathway: 510(k) (Traditional)
- Applicant: Thd Spa
- Decided: Mar 14, 2017 after 258 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: 4 generations back to K931574 (1993). 7 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K120088: Mcompass Anorectal Manometry System, Medspira, LLC (2012) Summary page 4.

## Most influential descendants
- K180135: THD Anopress with THD SensyProbe (2018), 3 descendants of its own
- 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 Press Probe. THD Anopress may only be used by appropriately trained medical staff.

Source page: https://510kreport.com/device/K161785
Methodology: https://510kreport.com/methodology