510(k) · Cleared
ClearedCaretaker Platform, VitalStream Platform, CT5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caretaker Medical · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 13, 2021 as substantially equivalent to K151499 (Caretaker Medical, LLC, 2016) and 2 other predicates after an 81-day review. Its family tree reaches back 13 generations to 1997.
- Decided
- Aug 13, 2021
- Review
- 81 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K962603 (1997). 69 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- 1 generation backK181196 Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 2018
- This deviceK211588 Caretaker Platform, VitalStream Platform, CT5Caretaker Medical · 2021
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 7 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 6 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 5 generations backK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- 4 generations backK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- 3 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- 1 generation backK181196 Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 2018
- This deviceK211588 Caretaker Platform, VitalStream Platform, CT5Caretaker Medical · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −8 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −7 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −6 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −5 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| −4 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| −3 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| −2 | K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015 | — |
| −1 | K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | 2018 | — |
| 0 (this device) | K211588 | Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs…Summary page 4…Product Code: DXN –System, Measurement, Blood-Pressure, Non-Invasive Device Class: II 5) Predicate Devices: Caretaker4 Physiological Monitor (K151499, K163255), Caretaker Monitor (K181196) 6) Device Description: The Caretaker Platform is a hemodynamic monitoring sy… | 2016 |
| * | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Summary page 4…ct Code: DXN –System, Measurement, Blood-Pressure, Non-Invasive Device Class: II 5) Predicate Devices: Caretaker4 Physiological Monitor (K151499, K163255), Caretaker Monitor (K181196) 6) Device Description: The Caretaker Platform is a hemodynamic monitoring system that… | 2017 |
| * | K181196 | Caretaker Remote Display App and Caretaker Software LibrarySummary page 4…ood-Pressure, Non-Invasive Device Class: II 5) Predicate Devices: Caretaker4 Physiological Monitor (K151499, K163255), Caretaker Monitor (K181196) 6) Device Description: The Caretaker Platform is a hemodynamic monitoring system that non- invasively measures var… | 2018 |
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 24 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 69 ancestors have a recall of any class.
- 1 other device also cites its predicate K151499.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Caretaker Platform is intended for non-invasive, continuous or spot-check measurement of hemodynamic parameters. Parameters can be reported to an integrated screen and optionally to Remote Data Display Systems (RDDS) and/or the Caretaker Remote Monitor App via standard wireless or wired data transmission protocols. The device is intended for use by clinicians or other properly trained personnel on adult patients at rest.
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/K211588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211588: Caretaker Platform, VitalStream Platform, CT5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211588
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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