510(k) · Cleared
ClearedA Series and Q Series Patient Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Biolight Meditech Co., Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 18, 2014 as substantially equivalent to K120193 (Guangdong Biolight Meditech Co., Ltd., 2012) and 1 other predicate after a 238-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it.
- Decided
- Feb 18, 2014
- Review
- 238 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K963644 (1996). 15 ancestors in all, the oldest K923043 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 5 generations between
- 3 generations backK052362 Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc. · 2005
- 2 generations backK062613 Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
- 1 generation backK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- This deviceK131898 A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
Show all 9 generations
- Root · 9 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 8 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 7 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 6 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- 5 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- 4 generations backK040183 BISXAspect Medical Systems, Inc. · 2004
- 3 generations backK052362 Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc. · 2005
- 2 generations backK062613 Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
- 1 generation backK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- This deviceK131898 A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −8 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −7 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −6 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| −5 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| −4 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| −3 | K052362 | Bis Eeg Monitor, Model a-3000 | Aspect Medical Systems, Inc. | 2005 | — |
| −2 | K062613 | Bis Eeg Monitor View | Aspect Medical Systems, Inc. | 2007 | — |
| −1 | K072286 | Bis Eeg Vista Monitor System and Bisx | Aspect Medical Systems, Inc. | 2007 | 1 |
| 0 (this device) | K131898 | A Series and Q Series Patient Monitors | Guangdong Biolight Meditech Co., Ltd. | 2014 | — |
| +1 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
| +2 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K120193 | Any View Patient MonitorsSummary page 3…t is not intended for helicopter transport, hospital ambulance, or home use. 5. Predicate Device Identification Predicate Device 1 510(k) Number: K120193 Product Name: Any View Patient Monitors Manufacturer: Guangdong Biolight Meditech Co., Ltd Predicate Device 2… | 2012 |
| * | K072286 | Bis Eeg Vista Monitor System and BisxSummary page 3…0(k) Number: K120193 Product Name: Any View Patient Monitors Manufacturer: Guangdong Biolight Meditech Co., Ltd Predicate Device 2 510(k) Number: K072286 Product Name: Aspect Medical Systems BIS EEG VISTA Monitor System Manufacturer: Aspect Medical Systems, Inc. 6. De… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183687 | LifeWindow LW8 Lite | 2019 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K183687 (Digicare Biomedical Technology, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120193.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO 2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (C02), Anesthetic Gas (AG)…
Read the full statement (123 words)
Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO 2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (C02), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (HIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet).
The arrhythmia detection, ST segment analysis only applied to a single adult patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician.
It is not intended for helicopter transport, hospital ambulance, or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131898: A Series and Q Series Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131898
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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