Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
InBios International, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
329 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251595 | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | 2025-10-12 | 138 | 0 |
| K233358 | SCoV-2 Ag Detect Rapid Test | InBios International, Inc. | 2024-08-23 | 329 | 0 |
| DEN220044 | Active Anthrax DetectTM Plus Rapid Test | InBios International, Inc. | 2023-02-03 | 210 | 0 |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. | 2019-05-23 | 148 | 0 |
| K181473 | DENV Detect NS1 ELISA | InBios International, Inc. | 2018-08-27 | 84 | 0 |
| K161947 | Chagas Detect Plus Rapid Test | InBios International, Inc. | 2016-12-16 | 155 | 0 |
| K141341 | CL DETECT RAPID TEST | InBios International, Inc. | 2014-11-14 | 177 | 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