510(k) · Cleared
ClearedMatrix Mini ECG Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Instrumentation, LLC · DSI Detector And Alarm, Arrhythmia
Cleared on Apr 22, 2016 as substantially equivalent to K984033 (Welch Allyn, Inc., 1999) and 1 other predicate after a 214-day review. Its family tree reaches back 5 generations to 1993. 1 of the 16 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Apr 22, 2016
- Review
- 214 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K925411 (1993). 12 ancestors in all, the oldest K911598 (1991). 3 later devices descend from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 4 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- 3 generations backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- 2 generations backK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- 1 generation backK120774 Acuity Central Monitoring Station or Acuity Central Monitoring…Welch Allyn, Inc. · 2012
- This deviceK152701 Matrix Mini ECG MonitorGlobal Instrumentation, LLC · 2016
- Descendant · cites it directly · 2 of its ownK171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex…Welch Allyn, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK212473 Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK201635 MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021
Class I recalls in this family
- K970209 Capnocheck Plus2 generations back · 1997
Most influential descendants
Showing 3 of 3 · See all- K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc. · 2017 · cites it directly2descendants
- K212473Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022 · 2 generations on0descendants
- K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −4 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| −3 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| −2 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| −1 | K120774 | Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile… | Welch Allyn, Inc. | 2012 | — |
| 0 (this device) | K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | 2016 | — |
| +1 | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall… | Welch Allyn, Inc. | 2017 | 3 |
| +2 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | — |
| +2 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 1 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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 |
|---|---|---|---|
| * | K984033 | Atlas MonitorSummary page 4…Product Code – DRT (Atlas also includes BZQ function) Welch Allyn, Inc. 510(k) Number K984033 Acuity Central Monitoring Station (Supplemental Predicate Device… | 1999 |
| * | K120774 | Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT…Summary page 4…measurement and alarm) Product Code – DSI Welch Allyn, Inc. 510(k) Number K120774 Abbreviated 510(k) Matrix Mini ECG Monitor Page 1 of 16… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System… | 2017 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171621 (Welch Allyn, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K984033.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors,
general hospital and alternate professional healthcare environments. The system is indicated for use in pediatric and adult
patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152701: Matrix Mini ECG Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152701
Report an extraction error
Are you the manufacturer?
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