Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LSQ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971591 | INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG | David C. Bishop, Ph.D. | 1998-03-13 | 316 | 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 |
| K872129 | LATEX R. CONORII | Health Research, Inc. | 1987-08-19 | 78 | 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