# K925791: Exac-Temp & Clini-Temp Probe W/Temperature Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Feb 25, 1994 after 466 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, 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
- K200631: DeRoyal Temperature Monitoring Probe (2020), 2 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

## Recalls of this device
- Aug 17, 2012 · Class II · Z-0407-2013: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

Source page: https://510kreport.com/device/K925791
Methodology: https://510kreport.com/methodology