510(k) · Cleared
ClearedMetavision Clinical Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imdsoft, Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 29, 2002 as substantially equivalent to K992636 (Hewlett-Packard Co., 1999) after a 189-day review. Its family tree reaches back 5 generations to 1994. 5 later devices descend from it.
- Decided
- Jan 29, 2002
- Review
- 189 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K941811 (1994). 15 ancestors in all, the oldest K822695 (1982). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 1 generation backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- This deviceK012349 Metavision Clinical Information SystemImdsoft, Ltd. · 2002
- Descendant · cites it directly · 3 of its ownK113214 Tlink Data Management System (DMS)Terumo Cardiovascular Systems Corp. · 2012
- Descendant · 2 generations on · 2 of its ownK131816 Sorin Connect Data Management SystemSorin Group Deutschland GmbH · 2013
- Descendant · 3 generations on · 1 of its ownK170460 Sorin ConnectSorin Group Deutschland GmbH · 2017
- Descendant · 4 generations on · 0 of its ownK212003 ESSENZ Patient MonitorLivanova Deutschland, GmbH · 2021
- Descendant · cites it directly · 0 of its ownK143372 AWAREAmbient Clinical Analytics · 2015
Most influential descendants
Showing 5 of 5 · See all- K113214Tlink Data Management System (DMS)Terumo Cardiovascular Systems Corp. · 2012 · cites it directly3descendants
- K131816Sorin Connect Data Management SystemSorin Group Deutschland GmbH · 2013 · 2 generations on2descendants
- K170460Sorin ConnectSorin Group Deutschland GmbH · 2017 · 3 generations on1descendant
- K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH · 2021 · 4 generations on0descendants
- K143372AWAREAmbient Clinical Analytics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −4 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −3 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −2 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −1 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| 0 (this device) | K012349 | Metavision Clinical Information System | Imdsoft, Ltd. | 2002 | — |
| +1 | K113214 | Tlink Data Management System (DMS) | Terumo Cardiovascular Systems Corp. | 2012 | — |
| +2 | K131816 | Sorin Connect Data Management System | Sorin Group Deutschland GmbH | 2013 | — |
| +3 | K170460 | Sorin Connect | Sorin Group Deutschland GmbH | 2017 | — |
| +4 | K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | 2021 | — |
| +1 | K143372 | AWARE | Ambient Clinical Analytics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992636 | HP Carevue 9000 Clinical Information System, Model M2331ASummary page 1…ALLY MARKETED PREDICATE DEVICES MetaVision is substantially equivalent to the Hewlett-Packard Carevue 9000 Clinical Information System that was cleared for marketing as K992636 on August 31, 1999. DEVICE DESCRIPTION The MetaVision Graphical ICU Patient Information System is a clinical information system… | 1999 |
What descends from it? (5)
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 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K113214 (Terumo Cardiovascular Systems Corp., 2012) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K992636.
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.
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 MetaVision Graphical Patient Information System is indicated for use in data collection, display, management, and storage in the intensive care unit. The system is used in conjunction with independent patient bedside devices and systems, connected via a network. The way the system is used for generating patient records, computation of drug and fluid dosage and research tasks is determined by the health care providers, in terms of their environment…
Read the full statement (131 words)
The MetaVision Graphical Patient Information System is indicated for use in data collection, display, management, and storage in the intensive care unit.
The system is used in conjunction with independent patient bedside devices and systems, connected via a network.
The way the system is used for generating patient records, computation of drug and fluid dosage and research tasks is determined by the health care providers, in terms of their environment and requirements.
The MetaVision application is resident on a workstation that provides for data input and patient data display--to health care professionals.
Typically, a MetaVision system comprises several workstations connected via a network system to one or more servers. Data is stored and managed by servers.
The MetaVision system network can communicate with a number of remotely located patient care units.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012349: Metavision Clinical Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012349
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026