# Ihealth Labs, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 4 (2024–2025): 4 510(k) clearances
- Product codes: SCA (2), QYT (1), MWI (1)
- 510(k) review time since 2016: median 213 days, against 148 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wondfo USA Co, Ltd.: 2 (https://510kreport.com/company/wondfo-usa)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Andon Health Co, Ltd.: 1 (https://510kreport.com/company/andon-health)

## Recent decisions
- K251085: iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (Dec 12, 2025)
- K251092: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (Dec 12, 2025)
- K243146: iCare APP (Feb 3, 2025)
- K233842: iHealth COVID-19 Antigen Rapid Test (May 31, 2024)

Source page: https://510kreport.com/company/ihealth-labs