Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healthy.Io, Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023-09-08 | 347 | 0 |
| K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022-07-06 | 541 | 0 |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019-07-26 | 329 | 0 |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | 2018-07-18 | 271 | 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