Cleared Traditional

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

K251669 · Shanghai Draeger Medical Instrument Co., Ltd. · Cardiovascular

Sep 2025

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K251669 is an FDA 510(k) clearance for 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, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Shanghai Draeger Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 30, 2025, 123 days after receiving the submission on May 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number	K251669 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	September 30, 2025
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2900