# Einstein Works, LLC

- Location (FDA's records): Houston, TX
- FDA decisions: 3 (2019–2021): 3 510(k) clearances
- Product codes: FMI (3)
- 510(k) review time since 2016: median 166 days, against 186 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Waismed, Ltd.: 2 (https://510kreport.com/company/waismed)

## Its most-cited devices
- K182770: Adult Intraosseous Infusion Device (2019), cited by 1

## Recent decisions
- K211395: NIO-I (Jul 28, 2021)
- K191258: Intraosseous infusion device (Oct 23, 2019)
- K182770: Adult Intraosseous Infusion Device (Apr 9, 2019)

Source page: https://510kreport.com/company/einstein-works