510(k) Report

FDA applicant

Caretaker Medical, LLC

Charlottesville, VA6 decisions2016–20250 recalls

FDA records 6 decisions for Caretaker Medical, LLC (Charlottesville, VA) from 2016 to 2025: 6 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DXG (Computer, Diagnostic, Pre-Programmed…). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Caretaker Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Caretaker Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12018: 12021: 12022: 12025: 1
2016high 1 (2016) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Caretaker Medical, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive4decisions
  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function1decision
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 149 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 184 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker…Caretaker Medical, LLC · 20173cite it
  • K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs MonitorCaretaker Medical, LLC · 20162cite it
  • K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 20181cites it

What has FDA decided for it lately?

  • K251275VitalStream ART Connect; VitalStream-HemoCaretaker Medical · 2025
  • K213699CareTaker Monitor AppCaretaker Medical, LLC · 2022
  • K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical · 2021
  • K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 2018
  • K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker…Caretaker Medical, LLC · 2017
  • K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs MonitorCaretaker Medical, LLC · 2016

All 4 as Caretaker Medical, LLC →All 2 as Caretaker Medical →