# K850858: OB-PH - PH Test Paper

- Pathway: 510(k) (Traditional)
- Applicant: Uro Pharmaceuticals, Inc.
- Decided: May 24, 1985 after 84 days
- Product code: LNW (Paper, Obstetric Ph)
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K960648: Phem-Chek (1996), 3 descendants of its own
- K012230: Phem-Alert (2001), 1 descendant of its own
- K091287: VS-Sense Test (2009), 0 descendants of its own
- K032161: Phem-Alert (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K850858
Methodology: https://510kreport.com/methodology