# K931963: Sandhill Disposable Internal Reference PH Probe

- Pathway: 510(k) (Traditional)
- Applicant: Sandhill Scientific, Inc.
- Decided: Sep 28, 1994 after 525 days
- Product code: FFT (Electrode, Ph, Stomach)
- Device class: 1
- Regulation: 21 CFR 876.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013951: Sandhill Scientific Pediatec PH Probe (2002), 0 descendants of its own

## Recalls of this device
- Sep 24, 2003 · Not classified · Z-0104-04: Pouch containing pediatric probes was labeled as containing adult probes.
- Jan 8, 2003 · Not classified · Z-0466-03: Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.

Source page: https://510kreport.com/device/K931963
Methodology: https://510kreport.com/methodology