# K915170: Pymah Cold Sterilog Glutaraldehyde Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Pymah Corp.
- Decided: Jul 28, 1992 after 256 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K092346: Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171 (2010), 2 descendants of its own
- K103126: Trophon Chemical Indicator (2011), 1 descendant of its own
- K233413: Ultraphon Chemical Indicator (TRO-T and TRO-B) (2024), 0 descendants of its own
- K080750: Browne Rapicide Glutaraldehyde Indicator (2008), 0 descendants of its own
- K992341: Cidex Opa Solution Test Strip (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K915170
Methodology: https://510kreport.com/methodology