# K963608: Quantitative Sentinel System

- Pathway: 510(k) (Traditional)
- Applicant: Quantitative Medicine, Inc.
- Decided: Mar 11, 1997 after 182 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K833395 (1984). 4 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960109: Quantitative Sentinel System, Quantitative Medicine, Inc. (1996) Summary page 1.
- K852608: Spectra 400 Extended Surveillance & Alert System, Ge Medical Systems Information Technologies (1985) Summary page 2.

## Most influential descendants
- 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
- K143695: Central Monitoring System (2015), 1 descendant of its own
- K020661: Unity IS Patient Viewer (2002), 1 descendant of its own

## Indications for use
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.

Source page: https://510kreport.com/device/K963608
Methodology: https://510kreport.com/methodology