510(k) Report

510(k) · Cleared

Cleared

Connex Workstation

K120343510(k) SpecialCleared Feb 24, 201221-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Welch Allyn, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Feb 24, 2012 as substantially equivalent to K052160 (Welch Allyn, Inc., 2005) after a 21-day review. Its family tree reaches back 4 generations to 1993. 7 later devices descend from it.

Decided
Feb 24, 2012
Review
21 days
Class
Class II
Product code
MWI
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K925411 (1993). 7 ancestors in all, the oldest K913193 (1991). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2000: 1 other ancestor1991: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant cleared2022: 2 descendants cleared2020: 1 descendant cleared2025: 2 descendants clearedK925411 · Model 2041-PC/ST Cardiac Telemetry Monitor · Accucore, Inc. · 1993K972121 · Acuity Central Station · Protocol Systems, Inc. · 1997K022453 · Modification to Acuity Central Monitoring System · Welch Allyn Protocol, Inc. · 2002 · recalledK052160 · Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) · Welch Allyn, Inc. · 2005 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K052160 · Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) · Welch Allyn, Inc. · 2005 · recalledK022453 · Modification to Acuity Central Monitoring System · Welch Allyn Protocol, Inc. · 2002 · recalledK972121 · Acuity Central Station · Protocol Systems, Inc. · 1997K925411 · Model 2041-PC/ST Cardiac Telemetry Monitor · Accucore, Inc. · 19930+5
  1. Root · 4 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
  2. 3 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
  3. 2 generations backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
  4. 1 generation backK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
  5. This deviceK120343 Connex WorkstationWelch Allyn, Inc. · 2012
  6. Descendant · cites it directly · 6 of its ownK132807 Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc. · 2014
  7. Descendant · 2 generations on · 4 of its ownK151006 EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015
  8. Descendant · 3 generations on · 2 of its ownK202497 Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020
  9. Descendant · 4 generations on · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
  10. Descendant · 5 generations on · 0 of its ownK243837 iBSMIorbit Digital Technologies Private Limited · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12020: 12022: 22025: 2
2014high 2 (2022) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · See all
  • K132807Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc. · 2014 · cites it directly6descendants
  • K151006EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015 · 2 generations on4descendants
  • K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020 · 3 generations on2descendants
  • K242842ANNE View, Central HubSibel Health, Inc. · 2025 · 4 generations on1descendant
  • K243837iBSMIorbit Digital Technologies Private Limited · 2025 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K925411Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc.1993—
−3K972121Acuity Central StationProtocol Systems, Inc.1997—
−2K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc.20021
−1K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc.20052
0 (this device)K120343Connex WorkstationWelch Allyn, Inc.2012—
+1K132807Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc.2014—
+2K151006EarlySense Central Display Station (CDS)Earlysense, Ltd.2015—
+3K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.2020—
+4K242842ANNE View, Central HubSibel Health, Inc.2025—
+5K243837iBSMIorbit Digital Technologies Private Limited2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
202010
202220
202520
FIG. 1 — Lineage of K120343, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)
Summary page 1
…, Model 020XXXXX (Note: XXXXX-Various Config.) Welch Allyn, Inc. 510O(k) Number K052 160 Description of the Device: Connex Workstation is a Windows-based product that provides clinicians with a means to remotely…
Welch Allyn, Inc.20052

Also cleared against K052160: 5 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132807Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc.20146

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 19 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K132807 (Welch Allyn, Inc., 2014) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K052160.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

What is it indicated for?

The Connex Workstation 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.

Also cleared against K052160

5 other devices cite the same predicate.

  • K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc. · 2015
  • K120774Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity…Welch Allyn, Inc. · 2012
  • K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
  • K071805Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDatascope Corp. · 2007
  • K070204Link to Acuity Clinician NotifierWelch Allyn Protocol, Inc. · 2007

More from Welch Allyn, Inc.

111 FDA decisions under this applicant name. See the company

  • K243598Welch Allyn Connex® 360 (Multiple)Welch Allyn, Inc. · 2025
  • K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc. · 20241 recall
  • K223381iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
  • K212473Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
  • K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 20191 recall

Recent decisions in MWI

The MWI category page

  • K260801Sensinel Cardiopulmonary Management (CPM) SystemAnalog Devices · 2026
  • K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc. · 2026
  • K253417Masimo Root Monitoring SystemMasimo Corporation · 2026
  • K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026
  • K253436c-med0 alphaCosinuss GmbH · 2026

https://510kreport.com/device/K120343 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120343: Connex Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120343

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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