# K200319: HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Apr 2, 2020 after 55 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925006 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925006: Hydro-Temp Nicu and Skin Surface Temperature Senso, Deroyal Industries, Inc. (1994) Summary page 5.

## Indications for use
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.

Source page: https://510kreport.com/device/K200319
Methodology: https://510kreport.com/methodology