510(k) · Cleared
ClearedCentral Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · HGM System, Monitoring, Perinatal
Cleared on Mar 30, 2015 as substantially equivalent to K103172 (Civnet Communication, Ltd., 2011) and 1 other predicate after a 96-day review. Its family tree reaches back 6 generations to 1984. 1 later device descends from it.
- Decided
- Mar 30, 2015
- Review
- 96 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K833395 (1984). 21 ancestors in all, the oldest K771553 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 5 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 4 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 3 generations backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- 2 generations backK051175 Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006
- 1 generation backK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- This deviceK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK171178 Central Monitoring SystemEdan Instruments, Inc. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171178Central Monitoring SystemEdan Instruments, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −5 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −4 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −3 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| −2 | K051175 | Civ-OB Obstrical Monitoring Software Application | Civent Communications, Ltd. | 2006 | — |
| −1 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| 0 (this device) | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +1 | K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017 | 1 |
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 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103172 | Civ-OB (Plus)Summary page 4…ce is Class II. Notification Class III Certification and Summary 4. Predicate Device(s): CIV-ob Obstetrical Monitoring Software Application /K103172/ CIVNET Communication Ltd. Philips OB TraceVue Obstetrical Information Management… | 2011 |
| * | K081203 | OB Tracevue Obstetrical Information Management System with Release F.00Summary page 4…/K103172/ CIVNET Communication Ltd. Philips OB TraceVue Obstetrical Information Management System/K081203/ Philips Medizin System 5. Device Description: The Maternal Fetal Monitoring – Central Nurse System… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171178 | Central Monitoring System | 2017 | 0 |
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 31 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K171178 (Edan Instruments, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K103172.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting. The MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record. The MFM-CNS has…
Read the full statement (113 words)
The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.
The MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.
The MFM-CNS has display fields for the following obstetric data:
- patient demographics
- provider notes
- fetal heart rate (FHR)
- uterine activity (via tocodynamometry or IUP)
- fetal movement
- maternal heart rate
- SpO2
- non-invasive blood pressure (NIBP)
- respiratory rate
- temperature
- pulse
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143695: Central Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143695
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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