510(k) · Cleared
ClearedCiv-OB Obstrical Monitoring Software Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civent Communications, Ltd. · HGM System, Monitoring, Perinatal
Cleared on Feb 17, 2006 as substantially equivalent to K993008 (Marquette Medical Systems, Inc., 1999) and 1 other predicate after a 287-day review. Its family tree reaches back 4 generations to 1984. 4 later devices descend from it.
- Decided
- Feb 17, 2006
- Review
- 287 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K833395 (1984). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 3 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 2 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 1 generation backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- This deviceK051175 Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006
- Descendant · cites it directly · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK171178 Central Monitoring SystemEdan Instruments, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK153580 Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · cites it directly3descendants
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · 2 generations on1descendant
- K171178Central Monitoring SystemEdan Instruments, Inc. · 2017 · 3 generations on0descendants
- K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −3 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −2 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −1 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| 0 (this device) | K051175 | Civ-OB Obstrical Monitoring Software Application | Civent Communications, Ltd. | 2006 | — |
| +1 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +2 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +3 | K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017 | 1 |
| +2 | K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K993008 | Quantitative Sentinel SystemSummary page 2…The CIV-ob Obstetrical Monitoring Software Application is substantially equivalent to: * GE Marquette Medical Quantitative Sentinel System, cleared under K993008, Dec 6, 1999. * ClinComp. Intl CIS w/ FMRD, cleared under K931 133. Performance Standards: No performance standards… | 1999 |
| * | K931133 | Clinical Infor Syst (Cis) W/Fetal Monit Remote DispSummary page 2…equivalent to: * GE Marquette Medical Quantitative Sentinel System, cleared under K993008, Dec 6, 1999. * ClinComp. Intl CIS w/ FMRD, cleared under K931 133. Performance Standards: No performance standards have been established for such devices under Sections 514 of the Fe… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103172 | Civ-OB (Plus) | 2011 | 3 |
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 22 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K103172 (Civnet Communication, Ltd., 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K993008.
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 CIVNET CIV-ob software application is intended for automatic fetal monitor patient data management. The application does this by: a) Displaying on-line fetal heart rate and TOCO data received from the patient bed-side in a one-to-one representation as it is displayed on the fetal monitor paper printout. b) Providing the means to control and display multiple beds simultaneously. c) Providing automatic Archiving of the data. d) Provide the ability to…
Read the full statement (188 words)
The CIVNET CIV-ob software application is intended for automatic fetal monitor patient data management. The application does this by:
a) Displaying on-line fetal heart rate and TOCO data received from the patient bed-side in a one-to-one representation as it is displayed on the fetal monitor paper printout.
b) Providing the means to control and display multiple beds simultaneously.
c) Providing automatic Archiving of the data.
d) Provide the ability to interface with different fetal monitors operating with the same interface protocol.
e) Easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record.
f) Provide visual notification of when acquired fetal monitor heart rate exceed the user defined limits for high and low fetal heart rate and poor signal quality.
g) Providing the ability to record, with patient record, fluid input and output information that is defined by the user.
h) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
i) Providing the ability to print (locally or remote) patient records.
j) Providing the ability to review fetal monitor data remotely over the TCP/IP
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051175: Civ-OB Obstrical Monitoring Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051175
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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