Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ihealth Labs, Inc. · 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) |
|---|---|---|---|---|---|
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COV | Ihealth Labs, Inc. | 2025-12-12 | 247 | 0 |
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-1 | Ihealth Labs, Inc. | 2025-12-12 | 246 | 0 |
| K243146 | iCare APP | Ihealth Labs, Inc. | 2025-02-03 | 126 | 0 |
| K233842 | iHealth COVID-19 Antigen Rapid Test | Ihealth Labs, Inc. | 2024-05-31 | 179 | 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