# K925792: Exac-Temp & Clini-Temp Tympanic & Myocardial Probe

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Apr 8, 1994 after 508 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.
4 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K200631: DeRoyal Temperature Monitoring Probe (2020), 2 descendants of its own
- 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
- K061942: Tympanic Temperature Probe with Foam, Model M1024233; Without Foam Model M1024237 (2006), 0 descendants of its own

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3256-2026: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

Source page: https://510kreport.com/device/K925792
Methodology: https://510kreport.com/methodology