Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tago, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
155 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Tago, Inc. | 1984-06-01 | 36 | 0 |
| K841265 | TAGO DIFFU-GEN C-REACTIVE PROTEIN | Tago, Inc. | 1984-05-22 | 57 | 0 |
| K834218 | DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - | Tago, Inc. | 1984-05-11 | 155 | 0 |
| K840404 | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | Tago, Inc. | 1984-03-09 | 38 | 0 |
| K833129 | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 | Tago, Inc. | 1983-11-21 | 69 | 0 |
| K830611 | RA SCREENING TEST | Tago, Inc. | 1983-03-24 | 24 | 0 |
| K830531 | MONO SCREENING TEST | Tago, Inc. | 1983-03-17 | 27 | 0 |
| K830156 | HCG SCREENING TEST | Tago, Inc. | 1983-02-09 | 22 | 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