# Isothermal Systems, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 2 (1977–1980): 2 510(k) clearances
- Product codes: BXA (1), BZO (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K801087: Neonatal Breathing Circuit System (May 23, 1980)
- K771510: Servo-Pak Molel 0030 (Aug 16, 1977)

Source page: https://510kreport.com/company/isothermal-systems