Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Care Systems, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910109 | CARDIOSWISS CM-8 | Care Systems, Inc. | 1991-09-23 | 256 | 0 |
| K894858 | CARE 5000 SYSTEM | Care Systems, Inc. | 1989-10-12 | 73 | 0 |
| K874844 | CARE TELSTAT MODELS: MP 5010 AND MP 5020 | Care Systems, Inc. | 1988-02-09 | 77 | 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