Cleared Traditional

K251669 - IBP transducer adapter cable

Also marketed or referenced as:
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 is an FDA 510(k) clearance for IBP transducer adapter cable, manufactured by Shanghai Draeger Medical Instrument Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K251669 · Shanghai Draeger Medical Instrument Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
123d
Days
Class 2
Risk

K251669 is an FDA 510(k) clearance for the IBP transducer adapter cable, Argon/BD/Ohmeda, 2m. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Shanghai Draeger Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 30, 2025 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Draeger Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K251669

510(k) Number K251669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 50
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