FDA cleared the Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) from Unimed Medical Supplies, Inc. on Dec 1, 2025 under K251696, a traditional 510(k). The device falls under product code DQA, Oximeter, regulated at 21 CFR 870.2700 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Jun 2, 2025. The decision came 182 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: K253162 (Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)), 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)).