510(k) · Cleared
ClearedMonitoring Station, Connex (R) Central Station (CS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 31, 2014 as substantially equivalent to K120343 (Welch Allyn, Inc., 2012) after a 144-day review. Its family tree reaches back 5 generations to 1993. 6 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 144 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K925411 (1993). 8 ancestors in all, the oldest K913193 (1991). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 4 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- 3 generations backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- 2 generations backK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- 1 generation backK120343 Connex WorkstationWelch Allyn, Inc. · 2012
- This deviceK132807 Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK151006 EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK202497 Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK243837 iBSMIorbit Digital Technologies Private Limited · 2025
- Descendant · cites it directly · 0 of its ownK212473 Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151006EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015 · cites it directly4descendants
- K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020 · 2 generations on2descendants
- K242842ANNE View, Central HubSibel Health, Inc. · 2025 · 3 generations on1descendant
- K243837iBSMIorbit Digital Technologies Private Limited · 2025 · 4 generations on0descendants
- K212473Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −4 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| −3 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| −2 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| −1 | K120343 | Connex Workstation | Welch Allyn, Inc. | 2012 | — |
| 0 (this device) | K132807 | Monitoring Station, Connex (R) Central Station (CS) | Welch Allyn, Inc. | 2014 | — |
| +1 | K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015 | — |
| +2 | K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020 | — |
| +3 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
| +4 | K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025 | — |
| +1 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 2 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K151006 (Earlysense, Ltd., 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Connex Central Station (CS) 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 and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132807 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132807: Monitoring Station, Connex (R) Central Station (CS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132807
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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