# K993008: Quantitative Sentinel System

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Medical Systems, Inc.
- Decided: Dec 6, 1999 after 90 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K833395 (1984). 6 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963608: Quantitative Sentinel System, Quantitative Medicine, Inc. (1997). Our OCR of the scanned summary read K973608, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Quantitative Sentinel System”.
- K852608: Spectra 400 Extended Surveillance & Alert System, Ge Medical Systems Information Technologies (1985) Summary page 1.
- K894958: Model 410 Alert and Telecommunication System, Ge Medical Systems Information Technologies (1989) Summary page 1.
- K960109: Quantitative Sentinel System, Quantitative Medicine, Inc. (1996) Summary page 2.

## Most influential descendants
- 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
- K012718: Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System. (2001), 1 descendant of its own

## Recalls of this device
- Sep 25, 2008 · Not classified · Z-0112-2009: On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.
- Sep 25, 2008 · Not classified · Z-0456-2009: Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the de
- Jun 30, 2008 · Not classified · Z-2037-2008: Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application record

## Indications for use
The Quantitative Sentinel (QS) System's is intended for automatic patient data management. It does this by: (a) providing the user the ability to create and use electronic forms for entering, viewing and storing patient and facility related data (e.g. charts, forms, graphs, chalkboards, care plans, user reference manual). (b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record. (¢) providing visual notification of when acquired fetal monitor heart rate values exceed the user defined limits for high and low fetal heart rate and poor signal quality. (d) providing Spectra Alerts capabilities for fetal monitoring (surveillance). (e) providing automatic computations of physiologic indexes (e.g. nutrition). (f) providing calculations from user defined formulas (i.e. index calculator). (g) providing the ability to record, with the patient record, fluid input and output information that is defined by the user. (h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes. (i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk). () providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names) (k) providing the ability to review fetal monitor data (OB-Link) remotely over the internet.

Source page: https://510kreport.com/device/K993008
Methodology: https://510kreport.com/methodology