# K013951: Sandhill Scientific Pediatec PH Probe

- Pathway: 510(k) (Traditional)
- Applicant: Sandhill Scientific, Inc.
- Decided: Feb 28, 2002 after 90 days
- Product code: FFT (Electrode, Ph, Stomach)
- Device class: 1
- Regulation: 21 CFR 876.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931963 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931963: Sandhill Disposable Internal Reference PH Probe, Sandhill Scientific, Inc. (1994) Summary page 1.

## Indications for use
Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients

Source page: https://510kreport.com/device/K013951
Methodology: https://510kreport.com/methodology