Caretaker Medical, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Caretaker Medical, LLC” (first 2016, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 150 days. Since 2017 the median was 149 days, against 163 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 288 |
| 2017 | 1 | 151 |
| 2018 | 1 | 149 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 81 |
| 2022 | 1 | 127 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 155 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Caretaker Medical, LLC took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Caretaker Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251275 | VitalStream ART Connect; VitalStream-Hemo | DXG | 2025-09-26 | 155 |
| K213699 | CareTaker Monitor App | DXN | 2022-03-30 | 127 |
| K211588 | Caretaker Platform, VitalStream Platform, CT5 | DXN | 2021-08-13 | 81 |
| K181196 | Caretaker Remote Display App and Caretaker Software Library | DRG | 2018-10-03 | 149 |
| K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor | DXN | 2017-04-21 | 151 |
| K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor | DXN | 2016-03-18 | 288 |
Recalls
openFDA lists no recalls under a recalling firm named Caretaker Medical, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Caretaker Medical, LLC is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04685733: Caretaker Hemodynamic Parameters Validation (Completed, started 2018-02-01)
- NCT02942836: CareTaker Respiratory Rate Detection Study (Completed, started 2016-03)
- NCT02831777: CareTaker Self-Calibration Validation (Completed, started 2016-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Caretaker Medical, LLC?
FDA lists 6 510(k) clearances under the applicant name “Caretaker Medical, LLC” (first 2016, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Caretaker Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Caretaker Medical, LLC is 150 days. Since 2017: 149 days, versus 163 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Caretaker Medical, LLC?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 1).
Next steps
- See all 6 Caretaker Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code DXN, Caretaker Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.