# K253162: Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: Jun 5, 2026 after 252 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: 3 generations back to K962070 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121427: Unimed Temperature Probe, Unimed Medical Supplies, Inc. (2012) Summary page 5.

## Indications for use
Reusable Temperature Probes: Unimed Reusable Temperature Probes are intended to be used for monitoring temperature by applying them to the esophageal or rectal site, depending on model. The temperature probes are reusable and designed for use with compatible patient monitors. These probes should be applied to a patient only under direct supervision of a licensed physician or health care provider. Probes must be cleaned, disinfected, and inspected for damage before use. Disposable Temperature Probes: Unimed Disposable Temperature Probes are intended to be used for monitoring temperature by applying them to the esophageal or rectal site, depending on model. The temperature probes are disposable and designed for use with compatible patient monitors. These probes should be applied to a patient only under direct supervision of a licensed physician or health care provider.

Source page: https://510kreport.com/device/K253162
Methodology: https://510kreport.com/methodology