Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cares Built, Inc. — 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) |
|---|---|---|---|---|---|
| K003238 | SOLID STATE X-RAY IMAGING DEVICES | Cares Built, Inc. | 2001-10-01 | 349 | 0 |
| K010391 | ATLAS MULTI-PURPOSE DSA SYSTEM | Cares Built, Inc. | 2001-03-12 | 31 | 0 |
| K010392 | ATHENA REMOTE CONTROLLED RF SYSTEM | Cares Built, Inc. | 2001-03-12 | 32 | 0 |
| K010393 | APOLLO MOBILE C ARM SYSTEM | Cares Built, Inc. | 2001-03-12 | 32 | 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