# K925006: Hydro-Temp Nicu and Skin Surface Temperature Senso

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Jan 31, 1994 after 486 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051873: Disposable Temperature, Skin and Esophageal Probes (2005), 6 descendants of its own
- K121999: General Purpose Temperature Probe, Skin Temperature Probe (2013), 5 descendants of its own
- K181967: Disposable Temperature Probe (2018), 2 descendants of its own
- K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (2020), 1 descendant of its own
- K182755: Disposable Temperature Probe (2018), 1 descendant of its own

## Recalls of this device
- Oct 14, 2015 · Class II · Z-0345-2016: DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper

Source page: https://510kreport.com/device/K925006
Methodology: https://510kreport.com/methodology