510(k) · Cleared
ClearedQuantitative Sentinel System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantitative Medicine, Inc. · HGM System, Monitoring, Perinatal
Cleared on Mar 11, 1997 as substantially equivalent to K960109 (Quantitative Medicine, Inc., 1996) and 1 other predicate after a 182-day review. Its family tree reaches back 2 generations to 1984. 10 later devices descend from it.
- Decided
- Mar 11, 1997
- Review
- 182 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K833395 (1984). 4 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 1 generation backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- This deviceK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 4 of its ownK051175 Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006
- Descendant · 3 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · 4 generations on · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK020661 Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K993008Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · cites it directly9descendants
- K051175Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006 · 2 generations on4descendants
- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · 3 generations on3descendants
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · 4 generations on1descendant
- K020661Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −1 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| 0 (this device) | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| +1 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| +2 | K051175 | Civ-OB Obstrical Monitoring Software Application | Civent Communications, Ltd. | 2006 | — |
| +3 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +4 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +2 | K020661 | Unity IS Patient Viewer | General Electric Medical Systems Information Techn | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HGM device
- #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960109 | Quantitative Sentinel SystemSummary page 1…ation of Legally Marketed Equivalent Devices (Predicate Systems) Predicate System Manufacturer k Number Quantitative Sentinel System | Quantitative Medicine, Inc. (QMI) k960109 200 Harry S. Truman Pkwy. Annapolis, MD 21401 Corometrics Model 400 Extended Surveillance and Alerts (Spectra 400) Corometrics… | 1996 |
| * | K852608 | Spectra 400 Extended Surveillance & Alert SystemSummary page 2…Predicate Device Comparison of Technological Characteristics Parameter QMPI’s QS System | QMI’s Predicate QS Corometrics Version 4.04.0 _ System Spectra 400 (k960109) (k852608) Interface HIS, Yes Yes Fetal Monitors physiologic monitors Only ' Network architecture Ethernet, Token Off-the-shelf Proprietary… | 1985 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993008 | Quantitative Sentinel System | 1999 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 12.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K993008 (Marquette Medical Systems, Inc., 1999) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K960109.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (108 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963608 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963608: Quantitative Sentinel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963608
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026