Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carematix, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
116 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123020 | BLIP MODEL BP-700WF | Carematix, Inc. | 2012-11-28 | 61 | 0 |
| K100508 | CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B | Carematix, Inc. | 2010-05-05 | 72 | 0 |
| K073038 | CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B | Carematix, Inc. | 2008-01-11 | 74 | 0 |
| K040966 | MODIFICATION TO CAREMATIX WELLNESS SYSTEM | Carematix, Inc. | 2004-06-02 | 49 | 0 |
| K031840 | CAREMATIX WELLNESS SYSTEM | Carematix, Inc. | 2003-10-10 | 116 | 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