510(k) · Cleared
ClearedCiv-OB (Plus)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civnet Communication, Ltd. · HGM System, Monitoring, Perinatal
Cleared on Mar 11, 2011 as substantially equivalent to K051175 (Civent Communications, Ltd., 2006) and 1 other predicate after a 134-day review. Its family tree reaches back 5 generations to 1984. 3 later devices descend from it.
- Decided
- Mar 11, 2011
- Review
- 134 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K833395 (1984). 18 ancestors in all, the oldest K771553 (1977). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 4 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 3 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 2 generations backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- 1 generation backK051175 Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006
- This deviceK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK171178 Central Monitoring SystemEdan Instruments, Inc. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK153580 Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −4 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −3 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −2 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| −1 | K051175 | Civ-OB Obstrical Monitoring Software Application | Civent Communications, Ltd. | 2006 | — |
| 0 (this device) | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +1 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +2 | K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017 | 1 |
| +1 | K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051175 | Civ-OB Obstrical Monitoring Software ApplicationSummary page 2…CIV-ob (plus) - CJVNIET CIV-ob Obstetrical Software Application, cleared under K05 1175. - Barney Inc. BIRTHTRACK (A.K.A. CLM) Computerized Labor Monitoring System cleared under K… | 2006 |
| * | K082704 | Birthtrack (a.K.a. CLM)Summary page 2…leared under K05 1175. - Barney Inc. BIRTHTRACK (A.K.A. CLM) Computerized Labor Monitoring System cleared under K082704. without raising new safety and/or effectiveness issues. A discussion of substantial equivalence is pro… | 2009 |
What descends from it? (3)
2 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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K143695 (Edan Instruments, Inc., 2015) has gone furthest, with 1 descendant 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. 2011, this device’s year, is highlighted.
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-obTM (plus) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting
The CIVNET CIV-obTM (plus) is intended to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record.
The CIVNET CIV-obTM (plus) has display fields for the following obstetric data:
* Monitoring site details
* Patient demographics
* Provider notes
* FHR
* Uterine Activity (via tocodynamometry IP)
* Head Descent
* Cervix Dilation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103172: Civ-OB (Plus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103172
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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