# NZE: Hyperthermia Monitor

- Device class: 2; regulation: 21 CFR 870.5900; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 198 days (middle half 195–273)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2010: 1
- 2017: 1
- 2023: 1
- 2025: 2

## Most-cited predicates
- K100071: Emcoolspad (2010), cited by 5
- K061023: Thermosuit System (2006), cited by 2
- K231182: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (2023), cited by 1
- K162523: The IQool System (2017), cited by 1

Source page: https://510kreport.com/product-code/NZE
Data by year (CSV): https://510kreport.com/product-code/NZE.csv