510(k) · Cleared
Recalled · 2008Quantitative Sentinel System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Medical Systems, Inc. · HGM System, Monitoring, Perinatal
Cleared on Dec 6, 1999 as substantially equivalent to K963608 (Quantitative Medicine, Inc., 1997) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1984. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 6, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- HGM
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 3 generations to K833395 (1984). 6 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 2 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 1 generation backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- This deviceK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK051175 Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006
- Descendant · 2 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK020661 Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002
- Descendant · cites it directly · 1 of its ownK012718 Modification to Corometrics Model 120IS Maternal/Fetal Monitoring…Ge Medical Systems Information Technologies · 2001 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051175Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006 · cites it directly4descendants
- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · 2 generations on3descendants
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · 3 generations on1descendant
- K020661Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002 · cites it directly1descendant
- K012718Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System.Ge Medical Systems Information Technologies · 2001 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −2 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −1 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| 0 (this device) | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | — |
| +1 | K051175 | Civ-OB Obstrical Monitoring Software Application | Civent Communications, Ltd. | 2006 | — |
| +2 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +3 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +1 | K020661 | Unity IS Patient Viewer | General Electric Medical Systems Information Techn | 2002 | — |
| +1 | K012718 | Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System. | Ge Medical Systems Information Technologies | 2001 | 15 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K963608 | Quantitative Sentinel System 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”. | 1997 |
| * | K852608 | Spectra 400 Extended Surveillance & Alert SystemSummary page 1…cal K973608 System Systems, (formerly Quantitative Medicine, Inc.) 200 Harry S. Truman Pkwy. Annapolis, MD 21401 Corometrics Spectra-Tel Corometrics Medical Systems, | K852608, k894958 Telecommunications and Inc. Display System 61 Barnes Park Road North Wallingford, CT 06492 0037 510(k)… | 1985 |
| * | K894958 | Model 410 Alert and Telecommunication SystemSummary page 1…08 System Systems, (formerly Quantitative Medicine, Inc.) 200 Harry S. Truman Pkwy. Annapolis, MD 21401 Corometrics Spectra-Tel Corometrics Medical Systems, | K852608, k894958 Telecommunications and Inc. Display System 61 Barnes Park Road North Wallingford, CT 06492 0037 510(k): Quantit… | 1989 |
| * | K960109 | Quantitative Sentinel SystemSummary page 2…. [807.92(a)6] Predicate Device Comparison of Technological Characteristics Parameter QMI’s QS System QMI’s Predicate QS Corometrics Version 5.04.1 System Spectra-Tel (k960109) (k852608) Interface HIS, Yes Yes Yes physiologic monitors Network architecture | Ethernet, Token Ring, Off-the-shelf No network;… | 1996 |
What descends from it? (9)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2008 | Not classified | Z-0112-2009 | Software design | 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 design | 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 desired choice is selected, and an… |
| Jun 30, 2008 | Not classified | Z-2037-2008 | Software design | 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 recording non-identifiable patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K051175 (Civent Communications, Ltd., 2006) has gone furthest, with 4 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'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…
Read the full statement (213 words)
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.
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/K993008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993008: 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/K993008
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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