FDA cleared the IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter from Shanghai Draeger Medical Instrument Co., Ltd. on Sep 30, 2025 under K251669, a traditional 510(k). The device falls under product code DSA, Cable, Transducer And Electrode, Patient, (Including Connector), regulated at 21 CFR 870.2900 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 30, 2025. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shanghai Draeger Medical Instrument Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K250349 (Vista CMS), K252250 (Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)).