510(k) Report

510(k) · Cleared

Cleared

Talis EMR with Talis +ACG (Talis EMR with +ACG)

K233133510(k) TraditionalCleared Apr 1, 2024187-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

Talis Clinical, LLC · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Apr 1, 2024 as substantially equivalent to K213335 (Capsule Surveillance Technologies, Sas /Capsule Tech, Inc., 2022) after a 187-day review. Its family tree reaches back 30 generations to 1994.

Decided
Apr 1, 2024
Review
187 days
Class
Class II
Product code
MWI
Recalls
None
Predicates
1

Its longest line of descent runs back 30 generations to K941811 (1994). 178 ancestors in all, the oldest K844187 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2006: 5 other ancestors2007: 1 other ancestor2004: 12 other ancestors2003: 12 other ancestors2005: 2 other ancestors2002: 13 other ancestors2001: 7 other ancestors2000: 19 other ancestors1999: 10 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 10 other ancestors1992: 6 other ancestors1989: 2 other ancestors1995: 6 other ancestors1994: 2 other ancestors1993: 5 other ancestors1991: 6 other ancestors1990: 6 other ancestors1987: 1 other ancestor1985: 1 other ancestorK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×9: 9 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004) ×11: 11 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006), K061610 (2006), K063315 (2006) K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K082583 · Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK130401 · Alertwatch: or · Alertwatch, LLC · 2014K142106 · Decisio Health Patient Dashboard · Decisio Health, Inc. · 2015K213335 · Capsule Surveillance System · Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 20221990200020102020
Other ancestors, by generation 3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 6 other ancestors6 generations back: 29 other ancestors7 generations back: 54 other ancestors8 generations back: 18 other ancestors9 generations back: 17 other ancestors10 generations back: 12 other ancestors11 generations back: 8 other ancestors12 generations back: 1 other ancestor K213335 · Capsule Surveillance System · Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022K142106 · Decisio Health Patient Dashboard · Decisio Health, Inc. · 2015K130401 · Alertwatch: or · Alertwatch, LLC · 2014K082583 · Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K063315 · Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2006K061610 · Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−30−25−20−15−10−50
  1. Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 26 generations between
  3. 3 generations backK130401 Alertwatch: orAlertwatch, LLC · 2014
  4. 2 generations backK142106 Decisio Health Patient DashboardDecisio Health, Inc. · 2015
  5. 1 generation backK213335 Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022
  6. This deviceK233133 Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC · 2024
Show all 30 generations
  1. Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 29 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 28 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 27 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 26 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 25 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 24 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 23 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 22 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 21 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 20 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 19 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 18 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 17 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 16 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 15 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 14 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 13 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 12 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 11 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 10 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 9 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 8 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 7 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 6 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 5 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 4 generations backK082583 Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 3 generations backK130401 Alertwatch: orAlertwatch, LLC · 2014
  29. 2 generations backK142106 Decisio Health Patient DashboardDecisio Health, Inc. · 2015
  30. 1 generation backK213335 Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022
  31. This deviceK233133 Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−30K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−29K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−28K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−27K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−26K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−25K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−24K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−23K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−22K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−21K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−20K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−19K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−18K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−17K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−16K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−15K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−14K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−13K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−12K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−11K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−10K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−9K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−8K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−7K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−6K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−5K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−4K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20095
−3K130401Alertwatch: orAlertwatch, LLC2014—
−2K142106Decisio Health Patient DashboardDecisio Health, Inc.2015—
−1K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.2022—
0 (this device)K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198920
199060
199160
199260
199350
199420
199560
1996100
199770
1998130
1999100
2000190
200170
2002130
2003120
2004120
200520
200650
200710
200910
201010
FIG. 1 — Lineage of K233133, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K213335Capsule Surveillance System
Summary page 4
…ce Name Code Predicate Device Capsule Technologies, SAS / Capsule MWI K213335 Tech Inc. Capsule Surveillance System The Talis EMR with +ACG is s…
Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.2022—

Also cleared against K213335: 2 other devices →

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 30 years and passes through 12 companies; a new generation was cleared every 4 months on median.
  • 22 of the 178 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K213335.

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. 2024, 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?

+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems. Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility’s…

Read the full statement (149 words)

+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems.

Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility’s clinical physicians or appropriate medical staff under the direction of physicians.

+ACG is intended to support the Medical Facility’s efforts to improve compliance to their patient care protocols and achievement of their quality initiatives.

It is not intended to replace clinicians’ judgement, but rather to assist clinicians in making timely, informed decisions.

+ACG is not intended to be used for secondary monitoring.

+ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action.

+ACG only works with Talis EMR Products.

Indications for use as stated in the FDA summary.

Also cleared against K213335

2 other devices cite the same predicate.

  • K241958WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025
  • K240756Aitrics-VCAitrics Co., Ltd. · 2024

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/K233133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K233133: Talis EMR with Talis +ACG (Talis EMR with +ACG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233133

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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