510(k) · Cleared
ClearedCentral Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Biolight Meditech Co., Ltd. · HGM System, Monitoring, Perinatal
Cleared on Sep 7, 2016 as substantially equivalent to K103172 (Civnet Communication, Ltd., 2011) after a 267-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Sep 7, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K833395 (1984). 19 ancestors in all, the oldest K771553 (1977). No later device cites it as a predicate yet.
- 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 deviceK153580 Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2016
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) | 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 |
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 |
|---|---|---|---|
| * | K103172 | Civ-OB (Plus)Summary page 4…rinatal Regulation Number: 21 CFR 884.2740 Review Panel: Obstetrics/Gynecology 5. Identification of Predicate Device(s) 510(k) Number: K103172 Product Name: Obstetrical Data Management and Monitoring Software Application Model Name: CIV-OB (PLUS) 6.… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 19 ancestors have a recall of any class.
- 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. 2016, 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?
Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women’s vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure…
Read the full statement (97 words)
Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women’s vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153580: Central Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153580
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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