Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Caretaker Medical, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213699 | CareTaker Monitor App | Caretaker Medical, LLC | 2022-03-30 | 127 | 0 |
| K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | 2018-10-03 | 149 | 0 |
| K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, Ca | Caretaker Medical, LLC | 2017-04-21 | 151 | 0 |
| K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, Ca | Caretaker Medical, LLC | 2016-03-18 | 288 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda