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 Aug 1, 1996 as substantially equivalent to K833395 (Quantitative Medicine, Inc., 1984) and 1 other predicate after a 203-day review. Its family tree reaches back 1 generation to 1984. 18 later devices descend from it.
- Decided
- Aug 1, 1996
- Review
- 203 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K833395 (1984). 2 ancestors in all. 18 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- This deviceK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- Descendant · cites it directly · 10 of its ownK963608 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 · cites it directly · 3 of its ownK965008 Birthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. · 1997 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K963608Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997 · cites it directly10descendants
- 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
- K965008Birthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. · 1997 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| 0 (this device) | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| +1 | 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 | — |
| +1 | K965008 | Birthnet II Perinatal Patient Data Management System | Spacelabs Medical, Inc. | 1997 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 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 |
|---|---|---|---|
| * | K833395 | Sentinel SystemsSummary page 1…cation of Legally Marketed Equivalent Devices (Predicate Systems) Predicate System Manufacturer k Number Quantitative Sentinel Systcm Quantitative Medicine, Inc. (QMI) k833395 200 Harry S. Truman Pkwy Annapolis, MD 21401 Clinical Information System (CIS) with Fetal Monitor CliniComp. Intl. k931133 Remo… | 1984 |
| * | K931133 | Clinical Infor Syst (Cis) W/Fetal Monit Remote DispSummary page 1…inel Systcm Quantitative Medicine, Inc. (QMI) k833395 200 Harry S. Truman Pkwy Annapolis, MD 21401 Clinical Information System (CIS) with Fetal Monitor CliniComp. Intl. k931133 Remote Display (FMRD) 4510 Exccutive Drive San Diego. CA 92121 *SI5 - Substantial Equivalence decision [807.92(a)4 & 807.92(a)… | 1995 |
What descends from it? (18)
See all 184 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K963608 (Quantitative Medicine, Inc., 1997) has gone furthest, with 10 descendants of its own.
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 hardwarc. The device is intended for usc 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/K960109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960109: Quantitative Sentinel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960109
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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