Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intercare Diagnostics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
368 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941938 | THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE | Intercare Diagnostics, Inc. | 1994-08-05 | 106 | 0 |
| K920569 | INDXTM DIP-S-TICKSTM | Intercare Diagnostics, Inc. | 1993-02-09 | 368 | 0 |
| K901597 | INDX DIP S TICKS | Intercare Diagnostics, Inc. | 1990-12-21 | 260 | 0 |
| K893895 | HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL | Intercare Diagnostics, Inc. | 1989-07-25 | 56 | 0 |
| K862948 | CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) | Intercare Diagnostics, Inc. | 1986-10-17 | 73 | 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