510(k) · Cleared
Recalled · Class II · 2025Central 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 Sep 6, 2017 as substantially equivalent to K143695 (Edan Instruments, Inc., 2015) after a 138-day review. Its family tree reaches back 7 generations to 1984. It has been recalled once.
- Decided
- Sep 6, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- HGM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K833395 (1984). 22 ancestors in all, the oldest K771553 (1977). No later device cites it as a predicate yet.
- Root · 7 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 6 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 5 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 4 generations backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- 3 generations backK051175 Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006
- 2 generations backK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- 1 generation backK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- This deviceK171178 Central Monitoring SystemEdan Instruments, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −6 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −5 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −4 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| −3 | K051175 | Civ-OB Obstrical Monitoring Software Application | Civent Communications, Ltd. | 2006 | — |
| −2 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| −1 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| 0 (this device) | K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K143695 | Central Monitoring SystemSummary page 5…Regulatory Class: Class II 3. Predicate Device(s): 1. EDAN Instrument, Inc. Central Monitoring System, model MFM-CNS v3.82, K143695. The predicate device was not the subject of a recall and no reference devices were used in this submis… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2025 | Class II | Z-1151-2026 | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 22 ancestors have a recall of any class.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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. 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. MFM-CNS has display…
Read the full statement (159 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.
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.
MFM-CNS has display fields for the following obstetric data:
patient demographics
provider notes
fetal heart rate (FHR)
uterine activity
fetal movement
maternal heart rate
SpO2
non-invasive blood pressure (NIBP)
respiratory rate
temperature
pulse rate
MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.
Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records.
Lite has display fields for the following obstetric data:
patient demographics
provider notes
fetal heart rate (FHR)
uterine activity
fetal movement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171178: 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/K171178
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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