510(k) · Cleared
Recalled · 2011Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)
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 Dec 16, 2005 as substantially equivalent to K022453 (Welch Allyn Protocol, Inc., 2002) and 2 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1993. 38 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 2005
- Review
- 129 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K925411 (1993). 6 ancestors in all, the oldest K913193 (1991). 38 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 2 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- 1 generation backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- This deviceK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005
- Descendant · cites it directly · 17 of its ownK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
- Descendant · 2 generations on · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
- Descendant · 3 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · cites it directly · 7 of its ownK120343 Connex WorkstationWelch Allyn, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK132807 Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc. · 2014
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010 · cites it directly17descendants
- K113165Mini-MedicAthena Gtx · 2012 · 2 generations on13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 3 generations on12descendants
- K120343Connex WorkstationWelch Allyn, Inc. · 2012 · cites it directly7descendants
- K132807Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc. · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −2 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| −1 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| 0 (this device) | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | — |
| +1 | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | — |
| +2 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| +3 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +1 | K120343 | Connex Workstation | Welch Allyn, Inc. | 2012 | — |
| +2 | K132807 | Monitoring Station, Connex (R) Central Station (CS) | Welch Allyn, Inc. | 2014 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K022453 | Modification to Acuity Central Monitoring SystemSummary page 1…Predicate Device: The subject device has the same indications for use as the predicates. K022453 Acuity® Central Monitoring System Welch Allyn Protocol, Inc. K972121 Acuity Central Station… | 2002 |
| * | K972121 | Acuity Central StationSummary page 1…s the predicates. K022453 Acuity® Central Monitoring System Welch Allyn Protocol, Inc. K972121 Acuity Central Station Protocol Systems, Inc. K935846 Model Acuity Central Stat… | 1997 |
| * | K935846 | Model Acuity Central StationSummary page 1…Acuity® Central Monitoring System Welch Allyn Protocol, Inc. K972121 Acuity Central Station Protocol Systems, Inc. K935846 Model Acuity Central Station Protocol Systems, Inc. Device Description: Acuity® Central Monitoring Stati… | 1994 |
What descends from it? (38)
See all 386 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | 2010 | 17 |
| K120343 | Connex Workstation | 2012 | 7 |
| K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XX | 2007 | 5 |
| K120774 | Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT… | 2012 | 4 |
| K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | 2015 | 0 |
| K070204 | Link to Acuity Clinician Notifier | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2011 | Not classified | Z-2918-2011 | Software design | Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference. |
| May 1, 2009 | Not classified | Z-0349-2011 | Other | The 19" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the power supply section. The faulty capacitors may cause a loss of power to the display resulting in the display screen going dark… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K101674 (Athena Gtx, 2010) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K022453.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended 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 optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis. * Full Disclosure stores patient data for up to…
Read the full statement (167 words)
The Acuity® Central Monitoring Station is intended 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 optional 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/K052160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052160: Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052160
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