Cleared Traditional

K251669 - IBP transducer adapter cable, Argon/BD/Ohmeda, 2m (FDA 510(k) Clearance)

Also includes:
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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 104
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