510(k) · Cleared
ClearedLink to Acuity Clinician Notifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn Protocol, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Mar 23, 2007 as substantially equivalent to K052160 (Welch Allyn, Inc., 2005) and 1 other predicate after a 60-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 23, 2007
- Review
- 60 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000647 (2000). 12 ancestors in all, the oldest K913193 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- 4 generations backK013387 Datex-Ohmeda S/5 Web ViewerDatex-Ohmeda · 2002
- 3 generations backK023497 Datex-Ohmeda S/5 Web Viewer with L-6WV02 SoftwareDatex-Ohmeda · 2002
- 2 generations backK033078 Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03…Datex-Ohmeda · 2003
- 1 generation backK052975 Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and…GE Healthcare · 2006
- This deviceK070204 Link to Acuity Clinician NotifierWelch Allyn Protocol, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000647 | Datex-Ohmeda Network and Central | Datex-Ohmeda, Inc. | 2000 | — |
| −4 | K013387 | Datex-Ohmeda S/5 Web Viewer | Datex-Ohmeda | 2002 | — |
| −3 | K023497 | Datex-Ohmeda S/5 Web Viewer with L-6WV02 Software | Datex-Ohmeda | 2002 | — |
| −2 | K033078 | Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software | Datex-Ohmeda | 2003 | — |
| −1 | K052975 | Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda… | GE Healthcare | 2006 | — |
| 0 (this device) | K070204 | Link to Acuity Clinician Notifier | Welch Allyn Protocol, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Summary page 1…tors (MSX) Detector and Alarm, Arrhythmia (DSI) Common/Usual Names: Central monitoring system Predicate Devices: K052160 Acuity® Central Monitoring Station Welch Allyn Protocol, Inc. K052975 S/5 Pocket Viewer… | 2005 |
| * | K052975 | Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5…Summary page 1…Names: Central monitoring system Predicate Devices: K052160 Acuity® Central Monitoring Station Welch Allyn Protocol, Inc. K052975 S/5 Pocket Viewer Datex-Ohmeda Device Description: The Acuity® Central Monitoring System, in… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 5 other devices also cite its predicate K052160.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities. In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and…
Read the full statement (251 words)
The Acuity® Central Monitoring System, in all configurations including the hardwired and
wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by
clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare
facilities.
In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity
System software can include optional modules to provide extended recording and analysis of
patient data. Acuity System software can include the following optional modules:
· The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT
and Mobile Acuity LT).
* The Arrhythmia Analysis 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 Analysis module is
not intended for use with neonatal patients.
* The ST Analysis module provides real-time monitoring and alarms for ST segment deviations
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 option is not intended for use with neonatal patients.
* The Welch Allyn Connectivity Server (WACS) module consists of a server platform on
which one or more of the following software options are installed: Link To Acuity (Acuity
System patient information delivered to mobile devices running Clinician Notifier software),
Web Server (Acuity System patient printout files available on Web browsers) and HL7
options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070204: Link to Acuity Clinician Notifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070204
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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