510(k) · Cleared
ClearedAMC Health CareConsole
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amc Health · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Sep 27, 2024 as substantially equivalent to K151839 (Amc Health, 2016) and 2 other predicates after a 344-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Sep 27, 2024
- Review
- 344 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K910772 (1991). 34 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- 3 generations backK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- 2 generations backK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- 1 generation backK151839 AMC Health VitalCaregiving SystemAmc Health · 2016
- This deviceK233446 AMC Health CareConsoleAmc Health · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −7 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| −3 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| −2 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| −1 | K151839 | AMC Health VitalCaregiving System | Amc Health | 2016 | — |
| 0 (this device) | K233446 | AMC Health CareConsole | Amc Health | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K151839 | AMC Health VitalCaregiving SystemSummary page 5…Monitoring System Classification: Cardiovascular, MWI, 21 CFR 870.2300; DXH, 21 CFR 870.2920 Predicate Devices: Primary Device: AMC Health VitalCaregiving System K151839 Additional Devices: Vital Caregiving System K051544 AirStrip Remote Patient Monito… | 2016 |
| * | K051544 | Vitalcaregiving SystemSummary page 5…21 CFR 870.2920 Predicate Devices: Primary Device: AMC Health VitalCaregiving System K151839 Additional Devices: Vital Caregiving System K051544 AirStrip Remote Patient Monitoring K133450 Intended Use: The AMC Health CareConsole (“CareConsole”) is a… | 2005 |
| * | K133450 | Airstrip Remote Patient MonitoringSummary page 5…alth VitalCaregiving System K151839 Additional Devices: Vital Caregiving System K051544 AirStrip Remote Patient Monitoring K133450 Intended Use: The AMC Health CareConsole (“CareConsole”) is a software-only device used alongside vital signs monitoring devic… | 2014 |
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 33 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 34 ancestors have a recall of any class.
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. 2024, 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?
CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinician-scheduled monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications, alerts, and reports can be generated and data can be securely…
Read the full statement (207 words)
CareConsole is intended to be used in conjunction with biometric health care measuring devices,
mobile applications, and questionnaires to collect and store data, and for clinician-scheduled
monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from
a patient monitoring device to a central electronic log of patient information, from which
notifications, alerts, and reports can be generated and data can be securely viewed by healthcare
professionals, authorized caregivers, and patients. Clinicians would then determine how and when to
best treat their patients in response to the notifications, alerts, and biometric data. For use by
individuals 12 years and older who do not have an emergency health care condition.
• Data can be sent via intranet networks, the internet, landline telephones, cellular telephones,
and other mobile devices.
• The software supports communication between patients and clinicians, caregivers, or researchers,
such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages.
CareConsole is intended for use in capturing remote patient monitoring data from non-invasive
remote monitoring devices and to provide remote hospital-at-home level of care where determined
necessary by a health care professional. CareConsole is not intended for use in emergency
situations or by a patient in an acute care medical facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233446: AMC Health CareConsole.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233446
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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