Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Triangle Biomedical Sciences, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
147 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982301 | MICRO21 WITH URINE SEDIMENT ANALYSIS | Triangle Biomedical Sciences, Inc. | 1998-08-07 | 37 | 0 |
| K973050 | MICRO21 WITH WBC ESTIMATE | Triangle Biomedical Sciences, Inc. | 1997-11-07 | 84 | 0 |
| K971470 | MICRO21 WITH CEREBROSPINAL FLUID | Triangle Biomedical Sciences, Inc. | 1997-09-16 | 147 | 0 |
| K964165 | MICRO21 WITH NDNA | Triangle Biomedical Sciences, Inc. | 1997-01-03 | 78 | 0 |
| K960774 | MICRO21 WITH ANA | Triangle Biomedical Sciences, Inc. | 1996-05-22 | 86 | 0 |
| K960776 | MICRO21 WITH RETIC | Triangle Biomedical Sciences, Inc. | 1996-05-17 | 81 | 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