# Engstrom Medical

- Location (FDA's records): Sturgis, MI
- FDA decisions: 2 (1995–1995): 2 510(k) clearances
- Product codes: BYD (1), BZA (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Promedic, Inc.: 1 (https://510kreport.com/company/promedic)

## Its most-cited devices
- K954194: Disposable Hme/Filter (1995), cited by 1

## Recent decisions
- K954197: Disposable Flex Tube (Oct 26, 1995)
- K954194: Disposable Hme/Filter (Oct 20, 1995)

Source page: https://510kreport.com/company/engstrom-medical