510(k) · Cleared
ClearedClinical Alert Notification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Extension, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jul 11, 2013 as substantially equivalent to K103634 (Ascom (Us), Inc., 2011) after a 150-day review. Its family tree reaches back 6 generations to 1997. 5 later devices descend from it.
- Decided
- Jul 11, 2013
- Review
- 150 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962827 (1997). 7 ancestors in all, the oldest K945277 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 5 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 4 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 3 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 2 generations backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- 1 generation backK103634 Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011
- This deviceK130339 Clinical Alert NotificationExtension, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK152341 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK172586 Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK180472 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK241728 Vios Monitoring System (TM) Model 2050; Vios Central Station…Murata Vios, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK232354 Vios Monitoring System (TM) Model 2050; Vios Central Station…Murata Vios, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · cites it directly4descendants
- K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · 2 generations on2descendants
- K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2018 · 2 generations on1descendant
- K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc. · 2025 · 3 generations on0descendants
- K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −5 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −4 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −3 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −2 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| −1 | K103634 | Ascom Clinicalconnex Cardiomax | Ascom (Us), Inc. | 2011 | — |
| 0 (this device) | K130339 | Clinical Alert Notification | Extension, Inc. | 2013 | — |
| +1 | K152341 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +2 | K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018 | 4 |
| +2 | K180472 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2018 | — |
| +3 | K241728 | Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios… | Murata Vios, Inc. | 2025 | — |
| +3 | K232354 | Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios… | Murata Vios, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K103634 | Ascom Clinicalconnex CardiomaxSummary page 1…cations, Physiologic Monitors Substantially Equivalent Devices: Ascom Cardiomax, K103634 Description of Clinical Alert Notification The EXTENSION Clinical Alert Notification solution is a closed loop communic… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152341 | ViSi Mobile Monitoring System | 2015 | 4 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K152341 (Sotera Wireless, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K103634.
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. 2013, 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 EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care Information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is Important to patient care, nursing vigilance and overall hospital operatlions. The EXTENSION Clinical Alert Notification solution alerts and informs the…
Read the full statement (177 words)
The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care Information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is Important to patient care, nursing vigilance and overall hospital operatlions. The EXTENSION Clinical Alert Notification solution alerts and informs the clinician about critical patient alarms by drawing an Identified individual's attention to a defined patient condition in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. The EXTENSION Clinical Alert Notification solution Is not Intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with the EXTENSION Clinical Alert Notification solution.
The EXTENSION Clinical Alert Notification solution is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type acute care environments and Is not for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130339: Clinical Alert Notification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130339
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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