510(k) · Cleared
ClearedAWARE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambient Clinical Analytics · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Apr 2, 2015 as substantially equivalent to K012349 (Imdsoft, Ltd., 2002) and 1 other predicate after a 128-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Apr 2, 2015
- Review
- 128 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K941811 (1994). 17 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 2 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 1 generation backK012349 Metavision Clinical Information SystemImdsoft, Ltd. · 2002
- This deviceK143372 AWAREAmbient Clinical Analytics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −5 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −4 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −3 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −2 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −1 | K012349 | Metavision Clinical Information System | Imdsoft, Ltd. | 2002 | — |
| 0 (this device) | 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 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K012349 | Metavision Clinical Information SystemSummary page 4…hout Arrhythmia Detection or Alarms) Product code: MWI 5. Predicate devices: a. MetaVision Graphical Patient Information System, iMDsoft, Ltd. Cleared for marketing as K012349 on January 29", 2002, Product Code MW1. b. Intellivue Clinical Information Portfolio (ICIP), Philips Medical Systems. Cleared for… | 2002 |
| * | K100272 | Intellivue Clinical Information PortfolioSummary page 4…d for marketing as K012349 on January 29", 2002, Product Code MW1. b. Intellivue Clinical Information Portfolio (ICIP), Philips Medical Systems. Cleared for marketing as K100272 on April 14th, 2010, Product Codes DXJ, NSX. Ambient Clinical Analytics 2211st AVE SW, STE 202, Rochester, MN 55902 === Page 5… | 2010 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K012349.
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. 2015, 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?
AWARE™ js intended for use in the data collection, presentation, management and storage of patient information, and is used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network. This device is indicated for use by health care providers when providing patient care in an ICU and Emergency Department healthcare setting. ' AWARE is indicated for use in the clinical care of hospitalized adult and…
Read the full statement (200 words)
AWARE™ js intended for use in the data collection, presentation, management and storage of patient information, and is
used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network.
This device is indicated for use by health care providers when providing patient care in an ICU and Emergency
Department healthcare setting. '
AWARE is indicated for use in the clinical care of hospitalized adult and pediatric patient (newborn, infant, child, and
adolescent) with or at risk of critical illness.
AWARE is not an Electronic Medical Record (EMR) application and AWARE use is not intended to replace electronic
data management systems utilized by healthcare institutions such as an EMR, LIMS (Laboratory Information
Management System), PACS (Picture Archive Communication), patient medical device monitoring and alarm systems.
AWARE is not a medical Alarm System and AWARE use is not intended to replace medical Alarm Systems (including
monitors) within a healthcare institution. AWARE provides no auditory alerts nor does it provide monitoring and alerting
of life threatening situations such as a ventilator disconnection, asystolia, or arrhythmia. AWARE provides a visual [CU-
based status of events reported from the institutions’ source systems to aid in the clinical care decision process.
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/K143372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143372: AWARE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143372
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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