# K200631: DeRoyal Temperature Monitoring Probe

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Dec 23, 2020 after 288 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- 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 K925791 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925791: Exac-Temp & Clini-Temp Probe W/Temperature Sensor, Deroyal Industries, Inc. (1994) Summary page 4.
- K925792: Exac-Temp & Clini-Temp Tympanic & Myocardial Probe, Deroyal Industries, Inc. (1994) Summary page 4.

## Most influential descendants
- K251160: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) (2026), 0 descendants of its own
- K212945: Sterile Disposable Temperature Probe (2022), 0 descendants of its own

## Indications for use
The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface temperature. The probe is offered in the following three configurations: - General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities. - Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface. - Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the aural canal. The device is single use and for use by licensed healthcare practitioners only. The probes are designed to interface with DeRoyal-branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport, Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.

Source page: https://510kreport.com/device/K200631
Methodology: https://510kreport.com/methodology