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

FDA cleared the Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) from Unimed Medical Supplies, Inc. on Jun 5, 2026 under K253162, a traditional 510(k). The device falls under product code FLL, Continuous Measurement Thermometer, regulated at 21 CFR 880.2910 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 26, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Unimed Medical Supplies, Inc. has 6 other decisions in the tracker over the last 12 months: K260931 (Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)), K253964 (Disposable Neonatal NIBP Cuff (U1681S-C51N)), K251691 (Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)), K251696 (Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)).