510(k) · Cleared
ClearedVitalStream ART Connect; VitalStream-Hemo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caretaker Medical · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Sep 26, 2025 as substantially equivalent to K181372 (Retia Medical, LLC, 2018) after a 155-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Sep 26, 2025
- Review
- 155 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023960 (2003). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70 | Lidco, Ltd. | 2003 | — |
| −1 | K181372 | Argos | Retia Medical, LLC | 2018 | — |
| 0 (this device) | K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 DXG? 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 DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 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 |
|---|---|---|---|
| * | K181372 | ArgosSummary page 5…T Dock Classification: 21 CFR 870.1435 Product Code: DXG Device Class: II 5) Predicate Device: Argos Monitor by Retia Medical (K181372) 6) Device Description: The VitalStream ART Connect is an adapter to accept the analog output channel of commer… | 2018 |
| † | K181196 | Caretaker Remote Display App and Caretaker Software Library | 2018 |
| † | K211588 | Caretaker Platform, VitalStream Platform, CT5 | 2021 |
| † | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs… | 2017 |
| † | K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs… | 2016 |
| † | K213699 | CareTaker Monitor App | 2022 |
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 22 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K181372.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, 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 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The VitalStream ART Connect (aka VitalStream-Hemo) provides calibrated cardiac output/stroke volume (CO) and derived parameters, including cardiac index (Cl), stroke volume (SV), stroke volume index (SVI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), mean arterial pressure (MAP), heart rate (HR), and pulse pressure variation (PPV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA") (K211588, K163255, K151499). The device is intended for use on adult patients by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251275: VitalStream ART Connect; VitalStream-Hemo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251275
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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