510(k) · Cleared
Recalled · 2003Modification to Acuity Central Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn Protocol, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Aug 21, 2002 as substantially equivalent to K913193 (Protocol Systems, Inc., 1991) and 3 other predicates after a 26-day review. Its family tree reaches back 2 generations to 1993. 63 later devices descend from it. It has been recalled once.
- Decided
- Aug 21, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K925411 (1993). 5 ancestors in all, the oldest K913193 (1991). 63 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 1 generation backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- This deviceK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002
- Descendant · cites it directly · 38 of its ownK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- Descendant · cites it directly · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 18 of its ownK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- Descendant · 3 generations on · 17 of its ownK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · cites it directly · 17 of its ownK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · cites it directly38descendants
- K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · cites it directly20descendants
- K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · 2 generations on18descendants
- K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 3 generations on17descendants
- K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −1 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| 0 (this device) | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | — |
| +1 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| +1 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +2 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| +3 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +1 | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 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? (4)
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 |
|---|---|---|---|
| * | K913193 | Model 100 Central StationSummary page 1…s monitors, and the Mortara H-Scribe Holter system. The Acuity@Central Monitoring Station and Acuity software were cleared for market by the FDA under 510(k) submissions K913193, K935846 and K972121. The FlexNetR" communications network was cleared for market as part of K002725. The FlexNetm communications… | 1991 |
| * | K935846 | Model Acuity Central StationSummary page 1…s, and the Mortara H-Scribe Holter system. The Acuity@Central Monitoring Station and Acuity software were cleared for market by the FDA under 510(k) submissions K913193, K935846 and K972121. The FlexNetR" communications network was cleared for market as part of K002725. The FlexNetm communications network… | 1994 |
| * | K972121 | Acuity Central StationSummary page 1…ortara H-Scribe Holter system. The Acuity@Central Monitoring Station and Acuity software were cleared for market by the FDA under 510(k) submissions K913193, K935846 and K972121. The FlexNetR" communications network was cleared for market as part of K002725. The FlexNetm communications network has not chan… | 1997 |
| * | K002725 | Micropaq, Models 402 and 404Summary page 1…software were cleared for market by the FDA under 510(k) submissions K913193, K935846 and K972121. The FlexNetR" communications network was cleared for market as part of K002725. The FlexNetm communications network has not changed from the original submission. The software in the Acuity@ Central Monitoring… | 2000 |
| † | K004017 | H-Scribe | 2001 |
What descends from it? (63)
See all 635 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | 2005 | 38 |
| K122036 | Visi Mobile Monitoring System | 2012 | 20 |
| K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | 2010 | 17 |
| K031760 | Viewpoint Telemetry System | 2003 | 2 |
| K061675 | Vision VXC Central Station, Model 4300 | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 31, 2003 | Not classified | Z-0538-04 | Other | Potential failure to audibly alarm due to speaker hardware component failure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K052160 (Welch Allyn, Inc., 2005) has gone furthest, with 38 descendants of its own.
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 system is intended to be used by skilled clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. The Acuity system consists of the Acuity Central Monitoring Station, Acuity software, FlexNet communications network and Welch Allyn vital signs monitors. The vital signs monitors can operate standalone (according to their individual Intended Use Statement) or be networked to the Acuity central…
Read the full statement (254 words)
The Acuity system is intended to be used by skilled clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. The Acuity system consists of the Acuity Central Monitoring Station, Acuity software, FlexNet communications network and Welch Allyn vital signs monitors. The vital signs monitors can operate standalone (according to their individual Intended Use Statement) or be networked to the Acuity central monitoring station through the Acuity FlexNet communication network.
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 detected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
The most likely locations for patients monitored by an Acuity system are step-down units, telemetry departments, general medsurg floors and emergency departments. The Acuity system is available for sale only upon the order of a physician or licensed health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022453: Modification to Acuity Central Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022453
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