# K190208: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

- Pathway: 510(k) (Traditional)
- Applicant: Diversatek Healthcare
- Decided: Oct 3, 2019 after 241 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011472 (2001). 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)
- K062222: Unitip High Resolution Catheter, Unisensor AG (2007) Summary page 4.

## Recalls of this device
- Jun 4, 2025 · Class III · Z-2324-2025: Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components d

## Indications for use
The High Resolution Impedance Manometry (HRiM) Probe is intended for use by gastroenterologists, surgeons, and medically trained personnel for gastrointestinal tract studies to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data. The device is used in conjunction with a manometry system. Studies performed with this system require a skilled interpretation by a physician to aid in making a diagnosis of gastrointestinal motility disorders. The device is indicated for use on adult populations only.

Source page: https://510kreport.com/device/K190208
Methodology: https://510kreport.com/methodology