# K911801: Ketosite (TM)/Stat-Site (TM)/Ketosite (TM) Low-HI Con

- Pathway: 510(k) (Traditional)
- Applicant: Gds Technology, LLC
- Decided: Jul 1, 1991 after 69 days
- Product code: JIN (Nitroprusside, Ketones (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 1 cites it directly.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST (1999), 40 descendants of its own
- K052980: Liberty Glucose Control, Model 2120031 (2005), 19 descendants of its own
- K040814: Modification to Precision Xtra Advanced Diabetes Management System (2004), 16 descendants of its own
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos (2010), 10 descendants of its own
- K060706: Liberty Normal Glucose Control Solution (2006), 8 descendants of its own

Source page: https://510kreport.com/device/K911801
Methodology: https://510kreport.com/methodology