Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Self 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) |
|---|---|---|---|---|---|
| K860923 | EZ DETECT, 5 MINUTE STREP-A COLOR TEST | Self Care Systems, Inc. | 1986-05-16 | 66 | 0 |
| K854358 | EZ DETECH-URINE BLOOD TEST STICKS | Self Care Systems, Inc. | 1986-04-09 | 162 | 0 |
| K860028 | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL | Self Care Systems, Inc. | 1986-04-07 | 94 | 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