# Imeka Solutions, Inc.

- Location (FDA's records): Sherbrooke, CA
- FDA decisions: 3 (2023–2026): 3 510(k) clearances
- Product codes: QIH (3)
- 510(k) review time since 2016: median 91 days, against 150 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (2 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
- Omniscient Neurotechnology Pty Ltd (O8t): 1 (https://510kreport.com/company/omniscient-neurotechnology-o8t)

## Its most-cited devices
- K230913: ANDI (2023), cited by 1
- K252298: ANDI 2.0 (2025), cited by 1

## Recent decisions
- K261405: ANDI 2.2 (May 28, 2026)
- K252298: ANDI 2.0 (Oct 22, 2025)
- K230913: ANDI (Jul 25, 2023)

Source page: https://510kreport.com/company/imeka-solutions