# K833395: Sentinel Systems

- Pathway: 510(k) (Traditional)
- Applicant: Quantitative Medicine, Inc.
- Decided: Jan 10, 1984 after 102 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 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
- K960109: Quantitative Sentinel System (1996), 18 descendants of its own
- K963608: Quantitative Sentinel System (1997), 10 descendants of its own
- K993008: Quantitative Sentinel System (1999), 9 descendants of its own
- K051175: Civ-OB Obstrical Monitoring Software Application (2006), 4 descendants of its own
- K103172: Civ-OB (Plus) (2011), 3 descendants of its own

Source page: https://510kreport.com/device/K833395
Methodology: https://510kreport.com/methodology