# K191425: Hydro-Temp Neonatal Skin Temperature Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Jan 21, 2020 after 237 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 DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.

Source page: https://510kreport.com/device/K191425
Methodology: https://510kreport.com/methodology