510(k) · Cleared
ClearedAcuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity, Mobile LT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Apr 10, 2012 as substantially equivalent to K052160 (Welch Allyn, Inc., 2005) after a 27-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it.
- Decided
- Apr 10, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925411 (1993). 7 ancestors in all, the oldest K913193 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 3 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- 2 generations backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- 1 generation backK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- This deviceK120774 Acuity Central Monitoring Station or Acuity Central Monitoring…Welch Allyn, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK152701 Matrix Mini ECG MonitorGlobal Instrumentation, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex…Welch Allyn, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK212473 Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK201635 MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021
Most influential descendants
Showing 4 of 4 · See all- K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC · 2016 · cites it directly3descendants
- K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc. · 2017 · 2 generations on2descendants
- K212473Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022 · 3 generations on0descendants
- K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −3 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| −2 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| −1 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| 0 (this device) | K120774 | Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile… | Welch Allyn, Inc. | 2012 | — |
| +1 | K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | 2016 | — |
| +2 | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall… | Welch Allyn, Inc. | 2017 | 3 |
| +3 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | — |
| +3 | 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 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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.
Planning a device in DSI? 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? (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 |
|---|---|---|---|
| * | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Summary page 1…Alarm (including ST-segment measurement and alarm) Welch Allyn, Inc. 510(k) Number K052 160 Special 510(k) Acuity® Central Monitoring Station Page 1 of 4 Welc… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152701 | Matrix Mini ECG Monitor | 2016 | 3 |
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 19 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K152701 (Global Instrumentation, LLC, 2016) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K052160.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Acuity® Central Monitoring Station is intendled to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. in addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include operational modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis. * Full disclosure stores patient data for…
Read the full statement (167 words)
The Acuity® Central Monitoring Station is intendled to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.
in addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include operational modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis.
* Full disclosure stores patient data for up to 96 hours
* Arrhythmia monitoring module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
* ST analysis module provides real-time monitoring and alarms for ST segment deviations, from a reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120774 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120774: Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity, Mobile LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120774
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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